Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER   The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.
Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber.
Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER   The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures
Worldwide Distribution -- US including the states of  Texas, Nevada and Colorado., and the country of Belgium.
Quadra S Offset Broach Handle   The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches.
Northstar Zolpidem Tartrate Tablets USP 10 mg.  Manufactured for Northstar RX, LLC Memphis, TN 38141.  Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India
Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
R-30H , Diagnostic X-Ray Beam-Limiting Device.   In combination with any of below X-ray tubes    0.6/1.2P364DK-85, 0.6/1.2P324DK-125,    0.6/1.2P324DK-85, 0.6/1.2P38DE-85    Device Model # R-30H.    Subsequent Product Code: IZX    Product Usage:  The device is the beam-limiting device for X-ray Radiography.
Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006.  Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
R-20J , Diagnostic X-Ray Beam-Limiting Device.   In combination with any of below X-Ray tubes:   06/1.2P364DK-85, 0.6/1.2P324DK-125,  06/1.2P324DK-85, 0.6/1.2P38DE-85.    Product Usage:  The device is the beam-limiting device for X-ray Radiography.
0.7U163CS-36 In combination with below systems  MUX-100H, MUX-100D, MobileArt Evolution      Brand Name: MUX-100H.   Classification Name:  Mobile x-ray system.  Device Model#MUX-100H.    Product Usage:  The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
0.7/1.3U163CS-36 In combination with below systems  MobileArt Evolution, MobileDaRt Evolution    Product Usage:  The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
0.7/1.2JG326D-265      Product Usage:  The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
0.4/0.7JG326D-265AX/AT      Product Usage:  The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Nationwide distribution: USA including Puerto Rico.
Sysmex XE-2100 Automated Hematology System; an automated differential cell counter;  Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1     The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method, HydroDynamic Focusing (DC Detection), flow cytometry method (using a semiconductor laser), and SLS-hemoglobin method.
There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.
Sysmex XE-5000 Automated Hematology System; an automated differential cell counter;  Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7   The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Row DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results.
Sysmex XE-2100C Automated Hematology System; an automated differential cell counter;  Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4   The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
catalog ##053-2311-4, all serial numbers
WI   Expanded Recall:  AL, AR, CA, CO,FL, GA,  IA, IL,  IN, KY, KS,  MS, MI, MN, MO, NC, NE, NY, NM, OR, OH, OK, PA , SC, SD, TN, TX, WI.
Land O Lakes, Pheasant Starter A Medicated, Type C Medicated Feed.  Item # 1125000-301
Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted.
EXPANDED RECALL:  PURINA HONOR SHOW CHOW BROILER COMP AMP 0.0125% BMD50 MEDICATED, NET WEIGHT 50 LBS (22.67 KG), PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812, UPC 8 83576 01124 9, 0016637, 781B.
Lot Codes:  , 2MAY23MFI1, 2JUN11MFI3, 2JUN12MFI1, 2JUN14MFI3, 2JUN20MFI3, 2JUN28MFI3, 2JUL06MFI1, 2JUL16MFI3
Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted.   Recall expanded 7-26-12 to include other products due to the lack of added vitamin D.
EXPANDED RECALL:  PURINA HONOR SHOW CHOW TURKEY GROW/FINISH BMD50 PELLET MEDICATED,  NET WEIGHT 50 LBS (22.67 KG), PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812,  UPC 8 83576 01182 9, 801R,0017095.
Lot Codes:  2MAY23MFI1, 2MAY31MFI1, 2JUN12MFI3, 2JUN20MFI3, 2JUN27MFI1, 2JUL06MFI1, 2JUL11MF13, 2JUL18MFI1
EXPANDED RECALL:  PURINA HONOR SHOW CHOW TURKEY STARTER AMP .0125% BMD50 MEDICATED,  NET WEIGHT 50 LBS (22.67 KG), PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812,  UPC 8 83576 01183 6, 801T, 0017096.
Lot Codes:  2MAY31MFI1, 2JUN06MFI3, 2JUN11MF13, 2JUN19MFI3, 2JUN22MFI3, 2JUL03MFI1, 2JUL11MF13, 2JUL13MFI1
EXPANDED RECALL:  DUMOR SHOW POULTRY AMP .0125% BMD 50 MEDICATED, TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN 37027-6812, NET WEIGHT 40 LB (18.14 KG), UPC 7 49394 01890 0, 60VA, 0045400.
Lot Codes:  2JUN11MFI3, 2JUL11MFI3, 2JUL18MFI1
Land O Lakes Purina LLC is recalling two batches of Pheasants Starter A Medicated feed produced on 6/13/12 and 7/2/12 because there was a formulation error and Vitamin D was omitted. Recall expanded 7-26-12 to include other products due to the lack of added vitamin D.
EXPANDED RECALL:  DUMOR CHICK STARTER 24%, TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN 37027-6812, NET WEIGHT 50 LB (22.67 KG), UPC 7 49394 05739 8, 60X7   ,  0046443.
Lot Codes:  2MAY30MFI1, 2JUN13NST1A1, 2MAY31STJ1, 2JUN13MFI1, 2JUN14NST1A1, 2MAY31STJ3, 2JUN22MFI1, 2JUN19NST2A1, 2JUN05STJ2, 2JUL11MFI3, 2JUN20NST2A1, 2JUN20STJ1, 2JUL02NST2A1, 2JUN26STJ2, 2JUL16NST2A1, 2JUL03STJ2, 2JUL16STJ2
EXPANDED RECALL:  DUMOR POULTRY GROWER/FINISHER 15%, TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN 37027-6812, NET WEIGHT 50 LB (22.67 KG), UPC 7 49394 05737 4, 60Y7,  0046444.
Lot Codes:  2MAY23MFI1, 2JUN07NST1A1, 2MAY25STJ1, 2MAY29MFI1, 2JUN12NST1A1, 2MAY25STJ3, 2MAY31MFI1, 2JUN13NST2A1, 2JUN05STJ2, 2JUN01MFI1, 2JUN18NST1A1, 2JUN18STJ2, 2JUN05MFI1, 2JUN20NST1A1, 2JUN21STJ2, 2JUN08MFI1, 2JUN21NST2A1, 2JUL03STJ2, 2JUN13MFI1, 2JUN27NST1A1, 2JUN14MFI1, 2JUN28NST2A1, 2JUN18MFI3, 2JUL05NST2A1, 2JUN20MFI3, 2JUL06NST2A1, 2JUN22MFI1, 2JUL13NST2A1, 2JUN29MFI1, 2JUL18NST1A1, 2JUN29MFI3, 2JUL09MFI3, 2JUL09MFI1, 2JUL17MFI3, 2JUL20MFI3
EXPANDED RECALL:  PURINA DIAMOND MILLING 15% LAYER FEED 1.5 FLAX,  0041731,  60BQ, BULK NET WEIGHT, PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812.
EXPANDED RECALL:  PURINA CU PRIVETT BREEDER STARTER 60KK, 0044485, BULK NET WEIGHT AND    PURINA CU PRIVETT BREEDER GROWER, 60KL,  0044484,   BULK NET WEIGHT    PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812
EXPANDED RECALL:  PURINA TURKEYMAX FINISHER 3  VMY 10 MEDICATED, 806G,  0045481, BULK NET WEIGHT, PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812
EXPANDED RECALL:  PURINA CS PHEASANT GROWER AMP 0.0175% MEDICATED, 804A,  0038560, BULK NET WEIGHT, PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812
EXPANDED RECALL:  PURINA CU LATHROP AN LAY 16 FLAX,  61XU,  0058755, BULK NET WEIGHT,  PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812.
EXPANDED RECALL:  PURINA LATHROP BROILER FINISHER, 783Z,  3000846-201, BULK NET WEIGHT, PURINA MILLS, LLC, PO BOX 66812, ST. LOUIS, MO 63166-6812
Community Blood Centers of Florida, Inc.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Hoxworth Blood Center  UC Medical Center
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
The American National Red Cross - Southern Region
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Blood product, which did not meet the acceptable product specifications, were distributed.
USA (nationwide) including the states of  AL, CA, CO, CT, DC, DE, FL, IA, IL, IN, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA and WI.
Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge   This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Cartridges are leaking.  The leaking is observed when opening the wrapper that holds the reagent cartridge.
LifeSouth Community Blood Centers Inc - Birmingham Region
Blood product, which did not meet acceptable product specifications, was distributed.
Blood product, which did not meet the acceptable product specifications, was distributed.
Walter L. Shepeard Community Blood Center, Inc.
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
Community Blood Centers of South Florida, Inc.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, labeled 'leukoreduced', but which had not undergone leukoreduction, was distributed.
Platelets Pooled Leukocytes Reduced Irradiated
Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
Blood product, positive for the S-antigen but labeled as S-antigen negative, was distributed.
Blood products, which did not meet acceptable product specifications, were distributed.
Blood product, manufactured with an undetermined quantity of additive solution, was distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products,  with a low pH, was distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Interstate Blood Bank, Inc. of Wisconsin
California; Germany, Federal Republic of
Blood products, collected from a donor who was permanently deferred, were distributed.
Blood product, collected using expired cryo blood collection bag was distributed.
Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Worldwide Distribution - USA including DE,IL, NC, CA, CO, GA, KY, PA, MD, MN, NY, and MA and internationally to Austria, UAE, China, Argentina, Italy, Taiwan, Czech Republic, Australia, UK, India, Germany, Spain, France, South Africa, Malaysia, Japan, Lebanon, Korea, Greece, Saudi Arabia, Switzerland, Pakistan, Tunisia, Serbia, Morocco, Netherlands, Portugal, Truk, Belgium, and New Zealand
''***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***''   Ophthalmic surgery
''***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***''   Ophthalmic surgery
''***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***''   Ophthalmic surgery
''***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***''   Ophthalmic surgery
MAKR840, MALZ570, MALZ580, MAMQ990, MAMR000, MANP250, MAPR320, MAQD910
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood products, leukoreduced greater than five days after collection, were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product was distributed within the US to select supermarkets (not under the Giant Eagle banner) in OH AND PA.
Mango Medley, 16 oz (contains cantaloupe, honeydew, mango, grapes), distributed by Fresh Food Mfg, 2500 Love Road, Freedom, PA  15042, UPC 3003430338 (4 -16 oz clear plastic containers per case)
UPC 3003430338, all product with expiration dates of 8/11/2012 through 8/31/2012
Recalling firm was notified the Mangoes used in production of product were recalled by supplier (Splendid Foods) for possible Salmonella contamination.
Nationwide distribution: USA including states of: AZ, IL, KY, MD, MI, OH, OR, PA, TX and VA.
AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512.   Usage: Hospital Bed.
The ''Retaining washers & Clevis Pins'' provided with the AC -powered adjustable hospital beds may fail under certain circumstances. The pins at the top of the leg were disengaging from the channel. This may cause the bed frame to come off tracks or collapse.
Boule Con Diff US Tri Pack, 6 Vials.   For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule Con-Diff Tri pack Lot 1005-549 were low and out of the assay range.
Boule Con-Diff Hematology Control 9 vials.   For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and  WY.  Foreign: Brazil and Colombia
Boule Con-Diff Hematology Control   For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complaint stating the MCHC parameter of the Low Control of Boule Con-Diff US Tri Pack lot number 1102-575 recovered low and out of range.
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Biolox delta Ceramic Femoral Head Rx only, sterile
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Biolox Option Ceramic Femoral Head System Rx, sterile
Wagner SL Revision Stem, uncemented Sterile
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Metasul Durom Femoral component Sterile, Rx
MS-30 Distal centralizer, cemented, sterile, Rx
Wagner cone Prosthesis, uncemented, sterile, Rx
Anatomical Shoulder'' Fracture Humeral stem
zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340  PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345,   Glenoid M, cemented, sterile; REF 01.04214.370,   Glenoid L, cemented, sterile; REF 01.04214.400   PE Keeled Glenoid L, cemented, sterile; REF 01.04214.405
Anatomical Shoulder'' Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem
Anatomical Shoulder'' Inverse Humeral Cup
Anatomical Shoulder'' Inverse/Reverse Glenoid Sterile, Rx
Anatomical Shoulder'' Inverse/Reverse Humeral PE-Insert Sterile, Rx
Anatomical Shoulder'' Ball taper for humeral stem
Anatomical Shoulder'' Fracture Humeral Head
Original M.E. Mueller'' Low Profile Cup Sterile, Rx
Dynesys L.I.S. Stabilizing cord Rx, Sterile
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthru, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong.
Dynesys Top-Loading System Cannulated Pedicle + Set Screw
NCB-PT lateral proximal 3 hole tibial plate
Sirus intramedullary nail for tibia, cannulated
PR only. Product sold by the firm at retail.
''Tacos de Jueyes'' (Crab Tacos) - Food Service
Undeclared allergens: wheat, soy, crustacean shellfish (crab), and yellow #5
''Alcapurria Jueyes'' (Crab-filled fritters) - Food Service
Worldwide Distribution - USA (nationwide) and Canada
STA Satellite Automated Multi-Parameter Analyzer   This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite.
Hoffman LRF Telescopic Strut Short Stryker  Stryker Trauma AG  CH-2545 Seizach  Distributed in the USA by   Howmedica Osteonics Corp.  325 Corporate Drive  Mahwah, NJ 07430.    The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.
K113327 Catalog No:   Telescopic Strut Extra Short Hoffman LRF Length:  4933-0-100 :100-125mm (Black)  4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow)  4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue)  4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red);    Lot Code:  4933-0-100 Telescopic Strut Extra Short Hoffman LRF Length 100-125mm (Black)  X28937; Z04197; Z09163; Z09597; Z12135;     4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow)  X28961; Z04199; Z09161; Z09769; Z12012;     4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue)  X34352; Z04200; Z05068; Z09011; Z09598; Z10872;     4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red);  X28963 ;Z04429; Z09471; Z11686
Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater than 250 LBS.
AZ, CA, CO, ID, MD, MN, MT, OR, TX, WA and Canada.
Fresh Express, Hearts of Romaine, 18 oz, Fresh Express Incorporated, packed in clear flexible plastic package.
Product Code: S270A24, UPC 71279-26201, Best Use By Date: Oct 11.
Sample of Fresh Express Hearts of Romaine tested positive for Salmonella.
Fruit Mango Peeled & Halved, Ready-To-Eat Product, 2, 2.5-lb trays per case
Coast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & Vegetables are conducting a voluntary product recall of Kent's brand & Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with mangoes from this producer.
Mixes, Salsa Mango Papaya, Ready-To-Eat Product, 2, 5-lb trays per case
Fruit Mango Peeled & Diced 1/4, Ready-To-Eat Product, 2, 5-LB Trays per case
Fruit Mango Peeled & Diced 1/2, Ready To Eat Product, 2, 5-LB Trays per case
Fruit Mango Whole Peeled, Ready-To-Eat Product, 2, 5-LB Trays per case
Mixes, Salsa Mango Bucket, Ready To Eat Product, 1 Gal; & Salsa Mango packaged in 5-lb Trays with 2 trays per case.
Fruit Mango Peeled and Sliced, Ready To Eat Product, 2, 5-lb Trays per case
Mixes Salsa/Mango Pineapple, Ready To Eat Product, 2, 5-lb Trays per case
Worldwide Distribution-USA (nationwide) and the countries of  Canada, Europe, and Australia.
The brand name of the device is AlgiNot, a dental impression material. Product                                  Part Numbers          AlgiNot Intra Kit                           34683          AlgiNot Volume Refills                           34682           Lot Number 1-1017      AlgiNot is a Class II Medical Device. The device listing number this product is  0136496 and the establishment registration number for Kerr Corporation is 1815757.    Intended as an alternative to traditional alginate materials.
Product                                     Part Numbers    Lot Number      AlgiNot Intra Kit                34683    1-1017       AlgiNot Volume Refills                34682    1-1017
The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this product on  patients with loose teeth may result in possible tooth fracture or tooth extraction.
Worldwide distribution: USA (nationwide) including states of: AZ, GA, ID, IL, LA, MD, MO, MN, NC, NV, OK, PA, TN, TX, VA and WI; and country of: Italy.
Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039)   Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039)    Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (List Number 06F12-11; Lot Number 091039)    Usage: Assayed human plasma which may be used to verify the integrity of newly received i-STAT CK-MB cartridges.
Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039)   Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 2 (List #06F12-10; Lot Number 081039)    Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 3 (List #06F12-11; Lot Number 091039)
154 (06F12-09 (74) boxes; 06F12-10 (35) boxes and 06F12-11 (45) boxes.)  1 box contains six, 3ml plastic bottles.
Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039); i-STAT Level 2 (List #06F12-10; Lot Number 081039); and i-STAT Level 3 (List #06F12-11; Lot Number 091039) results may be generated below the lower value assignment range for some vials.
Kellogg's Frosted Mini Wheats , Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 96 ct case single serve,each Nt. Wt. 1 oz (28g);  18 oz carton; 24 oz carton; 30 oz., 70 ct case single serve, 70 oz carton Canadian product:  Kellogg's Mini-Wheats Original Frosted Cereal 440 G, 510 G,850 G,  1300 G, 1600 G carton
This voluntary recall is initiated due to the possible presence of fragments of flexible metal mesh from a faulty manufacturing part that were found in  certain Mini-Wheats cereal produced in a single Kellogg plant between April 1 and September 21, 2012.
Kellogg's  Mini Wheats, Unfrosted, Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 18 oz carton;  70 ct case single serve;  Canadian: Kellogg's Mini-Wheats Original cereal 12 ct, 850 G
Kellogg's Variety and Assortment Packs containing Frosted/ Unfrosted Mini Wheats, Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 10 ct; 30 ct, 72 ct , 96 ct.
Canadian Product: Kellogg's Mini Wheats, Brown Sugar Flavour Cereal, 6 ct., 10 ct, 12 ct, 16ct;   400G, 510G, 850 G, 1300 G
Products were released for distribution in US.
Jamba Juice brand Peanut Butter Moo'd Smoothie; All sizes (small, medium, large); A Blend Of: Nonfat Vanilla Yogurt (Contains Milk), Chocolate Moo'd Base (Contains Milk), Soymilk (Contains Soy), Ice, Bananas, Peanut Butter (Contains Peanuts); The product is processed and packaged by Jamba Juice Co.
No codes (Stop sale date: September 24, 2012)
The products were manufactured using peanut butter recalled by Sunland Inc. because it may be contaminated with Salmonella.
Jamba Juice brand Chunky Strawberry Topper; All sizes (small, medium, large); A Blend Of: Strawberries, Bananas, Nonfat Plain Yogurt (Contains Milk), Soymilk (Contains Soy), Organic Pumpkin Flax Seed Granola  (Contains Soy & Wheat), Peanut Butter (Contains Peanuts); Product is processed and packaged by Jamba Juice Co.
Worldwide Distribution-- US Distribution including the state of Ohio and the countries of Switzerland, Germany, France, Poland, Austria, Italy, Japan, Australia, Denmark, China, Sweden, Norway, Spain, United Kingdom, Netherlands, and Czech Republic.
ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35).   The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting
Serial Numbers:  all ABL80 FLEX CO-OX analyzers with sofware versions 1.30, 1.31, 1.32, 1.33, and 1.34.
The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters.
Worldwide Distribution - USA (nationwide) and Internationally to Ireland
Sunquest Laboratory, version 7.0   not available
Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.
Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.
Worldwide distribution: USA (nationwide) including states of: AZ, GA, MI, MS, NC, NY, PA, SC, and TX; and countries of: Austria, Australia, Belgium, Canada, People's Republic of China, Columbia, Denmark, Finland, Germany, India, Iran-Islamic Republic of, Ireland, Japan, Lebanon, Morocco, Pakistan, Poland, Russian Federation, Saudia Arabia, Spain, South Africa, Thailand, Turkey and United Kingdom.
S5 Single Roller Pump 150, Item Number: 10-80-00   The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a ''Fault in motor controller'' alarm message displayed on the system panel.  This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury.  An out of specification electrical component was determined to be the cause of some of these events.
S5 Double Roller Pump 85, Item Number: 10-85-00   The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
S5 Mast Roller Pump 85, Item Number: 10-88-60   The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
S5 Mast Roller Pump 150, Item Number: 10-88-00   The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Sorin C5 Perfusion System, Item number 58-00-00   The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
2 units (no product distributed within the US).
Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.
Trochar Scalpel Instrument (Surgical Punch)   OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail'' system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
US States: CA, WA, NC, DE, HI, MN, OH, NH, NY, and IL.   No international distribution.
Clemmy's Brand Peanut Butter Chocolate Chip Ice Cream, Pint Size, 16 OZ (437mL), UPC 8 94509 00231 9. Labeling reads in part: ''CLEMMY'S RICH AND CREAMY PEANUT BUTTER CHOCOLATE CHIP*** 100% SUGAR FREE LACTOSE FREE GLUTEN FREE, 16 OZ (473mL)***DIST BY: Clemmy's Ice Cream P.O.Box 1746, Rancho Mirage, CA 92270**''.   8pints per case.
UPC 8 94509 00231 9. Code Date Range 11038-12215.  Firm's explanation of Best By date:   The first production date of 11038 corresponds to 02/07/2011 and the most recent production date of 12215 corresponds to 08/02/2012.  The product carries a 2-year best by print requirement, in the MM/YY format, so expiration date range to list would be:  BB 02/13 through BB 08/14      BB 02/13 through BB 08/14
Clemmy's Ice Cream of Rancho Mirage, CA is initiating a voluntary recall of Peanut Butter Chocolate Chip 16 ounce containers of ice cream that contains peanut butter associated with the Sunland, Inc., recall.  The peanut butter used in this product has the potential to be contaminated with Salmonella.
The products were distributed in MO, KS, OK, AR
Belfonte Home Run Sundae Ice Cream, A Baseball Nut Blend of Chocolate Peanuts, Chocolate Coated Pretzels, and a Thick Fudge Swirl in Peanut Butter/Chocolate Ice Cream, 56 oz. (1.66L) Belonite Ice Cream Company, Kansas City, MO
Products may contain peanut butter base with potentially contaminated with Salmonella.
Belfonte Mama's Choice Premium Ice Cream, Reverse Peanut Butter Pie, Peanut Butter Coated Fudge Filled Cups, Peanut Butter Flakes and Swirled Chocolate Cookie Pie Crust Ribbon in Peanut Butter Ice Cream, 56 oz. (1.66L) Belonite Ice Cream Company, Kansas City, MO
Worldwide distribution, including Nationwide (USA) and the countries of Canada, Austria, Belgium, Bulgaria, Switzerland, Germany, Denmark, France, Estonia, Spain, Finland, Iceland, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Luxembourg, Netherlands, Monaco, Poland, Romania, Serbia, Slovenia, Turkey, Jersey, and Martinique.
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Part Numbers 601-0007 and 601-0010, all lots
The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130C. The correct sterilization temperature should be listed as 132C and/or 270F.
Product was distributed to California,  Illinois, New Hampshire, New York, Washington, and Wisconsin.
Chocolate Peanut Butter Non-Dairy Frozen Dessert is sold under brand Luna & Larry's Organic Coconut Bliss.  It is packaged in One Pint (473ml) StanPac paperboard container, 8 cups per case.  The UPC code 8 96767 00121 9.   The product is labeled in parts: ''***CHOCOLATE PEANUT BUTTER NON-DAIRY FROZEN DESSERT***Luna & Larry's ORGANIC COCONUT BLISS***1 PINT 473mL***''.
The product is stamped with 41-61 and a date range of Nov 11 2012 through  Oct 24 2013 printed on the bottom of the container
Luna & Larry's Coconut Bliss Chocolate Peanut Butter Non-Dairy Frozen Dessert is recalled because it has the potential to be contaminated with Salmonella.  The peanut butter used in the product is supplied and recalled by Sunland, Inc.
Philips Medical Systems (Cleveland), Inc.
Nationwide distribution: USA including states of: ME, MI, NY, and WI.
Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI.   Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.
Philips Medical Systems Cleveland), Inc.  is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution.
Organic NuttZo Omega-3 SEVEN Nut & Seed Butter, Net Wt. 16 oz (1lb) 454 g, UPC  894697002030.
JagRma LLC is recalling NuttZo Original Nut and Seed Butter because it may be contaminated with Salmonella.  The affected products contain a peanut butter ingredient supplied by Sunland, Inc who is recalling due to Salmonella.
Nationwide in the US and worldwide: Australia, Canada, Norway, New Zealand, Ireland, Italy, and United Kingdom.
PureFit Peanut Butter Bars, size 2 oz (56.7g) and box of 15 bars in 1 box/carton.   UPC 812787001008, 812787002005
PureFit is recalling PureFit Peanut Butter Crunch Bars because of possible Salmonella.  The peanut butter in the crunch bars was supplied by Sunland Inc., and it is on recall because it may be contaminated with Salmonella.
CT, MA, NY, NJ, PA, DE, MD, DC, VA, GA, FL, IL, WI, MN, IN, TX, AZ, NV, and CA
Starbucks Protein Bistro Box, Net Wt 6.8 OZ (193g),  Contains Cage-free egg, white Cheddar Cheese, multigrain muesli bread with honey peanut butter spread and fruit.
Starbucks Protein Bistro Boxes contain Honey Peanut Butter Squeeze Packs which are involved in Justin's Nut Butter expanded recall.
New York, Maine, New Hampshire, Massachusetts and Vermont
Hannaford Red Velvet Cake Truffle, 6 count UPC #20335800000
Product labels fails to declare allergens: egg, milk, peanuts, wheat, soy and tree nuts
Hannaford Triple Chocolate Cake Truffle, 6 count UPC # 20335700000
US states: AZ, CA, IL, NE, and TX. No international distribution.
Su-Nun Crushed Roasted Thai Red Pepper, 10.58 oz. 12 jars/case. Packaged in clear plastic jars, red plastic screw on lid, with a red and yellow label. The principal display label has a red background with a yellow oval that reads in part:''SU-NUN***BRAND***HOT***CRUSHED ROASTED THAI RED PEPPER''. Label on the back reads in part:''MANUFACTURED BY KHUN NAN CURRY PASTE FACTORY 149/375 Moo 13, Soi Pacific, Settakit Road, omm-Noi, Kratumband, Samutsakhon, 74130, Thailand***''.   No expiration date listed.
No lot codes. Only UPC code: 659613000770. Distribution dates July 2012 to October 2012.     No expiration date listed.
The recall was initiated in response to positive Salmonella resuts during FDA routine import sampling of the product.
Pennsylvania State University  Berkey Creamery
On site retail salesroom and internet customers
Penn State Creamery/Berkey Creamery Ice Cream -- Black Raspberry flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Best by dates falling on or between February 10, 2013 and August 11, 2013.
Erring on the side of caution and safety for the consuming public, the University Creamery at Penn State is voluntarily recalling all ice cream and frozen yogurt made between May 16, 2012 and August 11, 2012 because of isolated incidents involving reports of small plastic foreign objects in the product.
Penn State Creamery/Berkey Creamery Ice Cream --  Scholar's Chip flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Penn State Creamery/Berkey Creamery Ice Cream -- Strawberry-No Sugar Added flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Penn State Creamery/Berkey Creamery Ice Cream -- Keeny Beany Chocolate flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Penn State Creamery/Berkey Creamery Ice Cream -- German Chocolate Cake flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Penn State Creamery/Berkey Creamery Ice Cream -- Cookies-N-Cream flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Penn State Creamery/Berkey Creamery Ice Cream --  Chocolate Chip Cookie Dough flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Penn State Creamery/Berkey Creamery Ice Cream --  Chocolate Chocolate Nut flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Penn State Creamery/Berkey Creamery Ice Cream -- Strawberry flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Penn State Creamery/Berkey Creamery Ice Cream --  Strawberry Cheesecake flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Penn State Creamery/Berkey Creamery Frozen Yogurt - Vanilla flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
Penn State Creamery/Berkey Creamery Frozen Yogurt - Strawberry flavor; 3 gallon (paper), 1/2 gallon (paper), and pints (plastic)
Green & Black's Organic Peanut & Sea Salt Milk Chocolate Bar NET WT. 3.5 oz (100g).  UPC 708656 100562.
Mondelez Global LLC (Mondelez Global) is voluntarily recalling the U.S. Green & Black's Organic Peanut & Sea Salt Milk Chocolate Bar (3.5 oz.) in response to the recently expanded recall of certain peanut products by Sunland Inc., Portales, NM (Sunland). This product contains peanuts supplied by Sunland. According to Sunland, the peanuts may be contaminated with Salmonella.
Creative Energy Foods manufactured nutrition bars with peanuts from Sunland, Inc which are under recall for the potential to be contaminated with salmonella.
Peanut Butter Cup Ice Cream: 1) Velvet Supreme Peanut Butter Cup 1/2 gallon MFD BY VELVET ICE CREAM CO., INC UTICA, OHIO 43080 1-800-589-5000; UPC #70682-10119; 2) Velvet Peanut Butter Cup, 3 gal, UPC #70682-10539
1 and 2 - Code Number #10181, MFD Date: 6/30/2010
The product was manufactured using peanut butter ingredient recalled by Sunland Inc. due to potential Salmonella contamination.
Velvet Buckeye Classic MFD BY VELVET ICE CREAM CO., INC UTICA, OHIO 43080 1-800-589-5000 56 oz  (UPC #70682-10038), 3 gallon (UPC #70682-10519)  and pints (UPC #70682-10423)
56oz- 801 units; 3 gal 585 units; Pints- 548 units
Product was distributed to one retail chain and 3 independent grocers in the State of Pennsylvania.
Turkey Hill Mint Chocolate Chip All Natural Ice Cream, 48 oz, UPC 0-20735-11203-8
The product contains undeclared coconut.
US states nationwide. No international distribution.
Nutrition bar. Crunch thinkThin Brand, Mixed Nuts, 40 grams. Packaged in plastic, labeled as:''Distributed by thinkproducts***Ventura, CA 93003***''.   10 bars/carton, 12 cartons/case. 120 bars per case
The firm inititated the recall of Crunch thinkThin nutrition bars which may contain blanched roasted peanuts supplied by Sunland , Inc and have the potential to be contaminated with Salmonella.
Nutrition bar. Crunch thinkThin Brand, White Chocolate Dipped Mixed Nuts, 40 grams. Packaged in plastic, labeled as:''Distributed by thinkproducts***Ventura, CA 93003***''.   10 bars/carton, 12 cartons/case. 120 bars per case
Nutrition bar. Crunch thinkThin Brand, Chocolate Dipped Mixed Nuts, 40 grams. Packaged in plastic, labeled as:''Distributed by thinkproducts***Ventura, CA 93003***''.   10 bars/carton, 12 cartons/case. 120 bars per case
Nutrition bar. Crunch thinkThin Brand, Caramel Chocolate Dipped Mixed Nuts, 40 grams. Packaged in plastic, labeled as:''Distributed by thinkproducts***Ventura, CA 93003***''.   10 bars/carton, 12 cartons/case. 120 bars per case
Nutrition bar. Crunch thinkThin Brand, Cherry & Mixed Nuts, 40 grams. Packaged in plastic, labeled as:''Distributed by thinkproducts***Ventura, CA 93003***''.   10 bars/carton, 12 cartons/case. 120 bars per case
Nutrition bar. Crunch thinkThin Brand, Blueberry & Mixed Nuts, 40 grams. Packaged in plastic, labeled as:''Distributed by thinkproducts***Ventura, CA 93003***''.   10 bars/carton, 12 cartons/case. 120 bars per case
Nutrition bar. Crunch thinkThin Brand, Cranberry Apple & Mixed Nuts, 40 grams. Packaged in plastic, labeled as:''Distributed by thinkproducts***Ventura, CA 93003***''.   10 bars/carton, 12 cartons/case. 120 bars per case
IL, IN, ME,. MO, NJ, NY, OH, PA, TN and WI
Dole American Blend; Iceberg, Romaine, Red Cabbage, Carrots and Radishes.  Net Wt. 12 oz. (340g)  UPC 0 71430 00933 8  Distributed by Dole Fresh Vegetables, Monterey, CA 93940
Tennessee Department of Agriculture collected a random sample of Dole American Blen and had a positive result for Listeria Monocytogenes.
Natural Selection Foods LLC dba Earthbound Farm
CA, FL, HI, LA, MA, MT, NE, NJ, NY, OH, OR, PA, TX and Canada
Earthbound Farms Organic Baby Spinach Grab & Go Salad; with sesame, soy vinaigrette and peanuts. USDA Organic 3.5 oz. Clamshell package.  UPC 0 32601 08875 0  Natural Selection Foods  San Juan Bautista, CA.
Best if Used by Dates: 10/17-12 through 10/28/12.
Peanuts packaged with EarthBound Baby Spinach Grab & Go Salad were provided by Sunland through a third party and are under recall due to potential Salmonella contamination.
Peanuts in Shell, R&S, 8oz, Item#304, 12pk/case, UPC 070334003046. Peanuts in Shell, R&S, 8oz, Item#304P, 12pk/case, UPC 170334003046.  Peanuts in Shell, R&S, 8oz, Item#307, 36pk/case, UPC 070334003046.  Peanuts in Shell, R&S, 16oz, Item#317, 24pk/case, UPC 070334003176.  Peanuts in Shell, R&S Clip Strips, Item#327, 8oz, 4/12 pk/case, UPC 070334003046.  Peanuts in Shell, R&S, 4.5oz, Item#334, 12pk/case, UPC 070334003305.  Peanuts in Shell, R&S, Display Ready, 8oz, Item#360, 12pk/case, UPC 070334003046.  Peanuts in Shell, R&S, 3lbs, Item#383, 8pk/case, UPC 070334003831.  Peanuts in Shell, R&S, 3lbs, Item#530, 60pk/case, UPC 170334005309.  Peanuts in Shell, R&S, 3lbs, Item#530V, 60pk/case, UPC 070334005309.  Peanuts in Shell, R&S, 3lbs, Item#530VP, 60pk/case, UPC 070334005309.  Peanuts in Shell, R&S, 7.5lbs, Item#1950, 24pk/case, UPC 052679019500.
Trifecta Foods, LLC in Pacoima, CA is voluntarily recalling products containing In-Shell Roasted Salted and Unsalted Peanuts supplied to Trifecta Foods by Sunland, Inc. because they may be contaminated with Salmonella.
Peanuts in Shell, R Unsalted, 8oz, Item#305, 12pk/case, UPC 070334003053. Peanuts in Shell, R Unsalted, 8oz, Item#308, 36pk/case, UPC 070334003053.  Peanuts in Shell, R Unsalted, 16oz, Item#318, 24pk/case, UPC 070334003189.  Peanuts in Shell, R Unsalted-Display Ready, 8oz, Item#361, 12pk/case, UPC 070334003053.  Peanuts in Shell, R Unsalted, 3lbs, Item#384, 8pk/case, UPC 070334003848.  Peanuts in Shell, R Unsalted-Caddies, 3oz, Item#535, 8/12pk/case, UPC 070334005354.
AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12008 6.
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12008 6
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient.  Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair Lotion (benzoyl peroxide 10% w/v) AFCS-0303-00, and 1-count 1 oz (28 g) bottle AFSV-0305-03, Retinol Renewal Complex per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA  92618, UPC 7 88521 12900 3.
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12900 3
AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA  92618, AFCS-0101-00, UPC 7 88521 12020 8.
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12020 8
AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA  92618, AFCS-0402, UPC 7 88521 12030 7.
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 12030 7
AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA  92618, UPC 7 88521 13551 6.
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13551 6
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient.
AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA  92618, UPC 7 88521 13548 6.
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13548 6
Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient.  Additionally, this product is mislabeled because the label either omits or erroneously added inactive ingredients to the label.
AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA  92618, UPC 7 88521 13350 9.
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13550 9
AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA  92618, UPC 7 88521 13546 2.
All lots with expiration dates between 10/10/12 through 10/10/14 of UPC 7 88521 13546 2
Product was distributed in Washington state. There are no Canadian consignees.
Fiesta Mix 25 pound bags, with UPC 032491208597.    The product is labeled in part: ''***Fiesta Mix A Blend of the Sweet Crunchy and Salty Ingredient: Peanuts, honey, chili bits, corn, goldfish, nacho flavoring, vegetable oil, salt. *** 25 pounds (11.34 kg) net weight *** The Nut Factory 19425 East Broadway Avenue Greenacress, WA 99016***''.
Dates of distribution: 1/1/12 thorugh and including 10/17/12 Fiesta Mix label Date Manuactured: In format of date, first three letters of the month and year (2012).
13-25 pound bags (325 lbs of product total).
Fiesta Mix product is recalled due to undeclared soy, milk, wheat, and FD& C Yellow #6 on finished product label.
Worldwide Distribution--US (nationwide) including states of Alaska, California, Florida, Illinois, Michigan, South Carolina, and Texas., and the countries of Canada, Chile, France, Libya, Panama, Qatar, Saudi Arabia, Switzerland and  United Kingdom
The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches).  The display is an integrated LCD 19-Inch.     The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules.
169 units distributed (98 in US and 71 Internationally)
Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation.
Starbucks brand Protein Bistro Box. cage free egg, white cheddar cheese, multigrain muesli bread, apple slices, red grapes and peanut butter packet.  Net weight: 6.8 oz.     Starbucks Bistro box UPC 762111881502; Justin's honey Peanut Butter blend UPC 894455000391.  Honolulu Baking Co.  Honolulu, HI 96813
Enjoy By Dates of 9-2-10 - 3-28-12 and 9-1-12 - 10-1-12. for Bistro Boxes. Best Buy Dates for peanut packets: 4/11/11 _ 12/7/12; 7/27/13 and 7/29/13.
Firm used recalled 0.5 oz., single serve squeeze packs of Honey Peanut Butter in their Starbucks Brand Protein Bistro Packs which have been implicated in the Sunland Inc recall.
Peanut brittle, 2 lbs packaged in plastic bags (bulk product)
Products were manufactured using peanuts recalled by Sunland
Bacon Brittle, 2 lbs packaged in plastic bags (bulk product)
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of Austria, Australia, Brazil, Canada, Germany, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Croatia, India, Morocco, Mexico, Malaysia, Netherlands, New Zealand, Panama, Poland, Russian Federation, Solomon Islands, Singapore, Thailand, Turkey, Venezuela, South Africa, Chile, Colombia, Costa Rica, Slovenia, Argentina, China, and Taiwan.
AMS AdVance'' Male Sling System 720088-01   AMS AdVance'' Male Sling System (US)  720088-02   AMS AdVance'' Male Sling System (Intl)  72404224   AMS Male TO Sling System (Intl).    The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).
American Medical Systems (AMS) is issuing a voluntary recall on a number of lots of the AdVance Male Sling System (AdVance).   AMS has recently received a small number of complaints regarding the resorbable suture in the AdVance sling not lasting for the entire 15 month shelf life of the product.  An internal investigation has been conducted and confirmed that some sutures degraded prior to the expiration of the labeled shelf life. At this time AMS cannot confirm that there is no potential for premature degradation of the bioabsorbable tensioning sutures on the product included in this recall.
Williams and Company Inc dba The Nut Shop
The Nut Shop (brand) Roasted Peanuts, 3.0 oz MIN Wt.
The product is not coded.  All product on the shelf as of October 18, 2012
Product manufactured using peanuts which were recalled by Sunland.
ULTRA Fabric Reinforced surgical Gown X-Large Sterile   The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile   The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Nationwide Distribution including  TN, WI, and FL.
TI Standard Polyaxial Screw Assembly 6.5MM x 55MM.  Part # 62065-55.   Subsequent Product Codes:  MNH, MNI.    The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM.