Worldwide Distribution - USA (nationwide)
STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs.   The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of the product's labeled shelf-life.
Blood products, for which donor's whole blood unit was screened for hemoglobin utilizing the hemocue was not quality controlled, was distributed.
Northern California Community Blood Bank
Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
Blood products, labeled with the incorrect expiration date, were distributed.
Blood products, collected from a donor who did not have a physical examination, were distributed.
Corneas, recovered from a donor who had not been properly evaluated for hemodilution, were distributed.
All direct consignees located within the state of CA.
Flavored coffee. Cafe Moto Almond Truffle Flavored Coffee, 16 oz.
The recall was initiated because the Almond Truffle flavoring used in the manufacturing of the recalled product contains a small percentage of whey, a milk derivative.
Corneas were distributed to Jordan Eye Bank, Jordan University Hospital, Queen Rania Street, Amman, Jordan
Human Cornea, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distributed to distributor and retail in US State of TX.
Nestle Nesquik Chocolate Flavor, chocolate beverage powder, New Wt 48.7 OZ. Product labeling reads in part:''***Nestle Nesquick Chocolate FLAVOR*** NET WT***48.7OZ***DISTRIBUTED BY***NESTLE USA, INC., GLENDALE, CA 91203 USA***''.
Recalled product under following Batch number: 210458802G, 210558802G, 210758803G, 210658801g, 210658801G.    Code Date Breakdown:  2-Year code (2012)  104-Julian code  5880-plant code  2-shift  G-line designation
Firm initiated recall due to potential contamination with metal fragments.
Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Blood products, for which testing for hepatitis B surface antigen was invalid, were distributed.
Bacterin International Inc. Biologics Division
Tendon products are derived from donated cadaver human tissue. They were prepared from tissue procured from a cadaver donor using aseptic surgical techniques.    Each donor receives a Bacterin ID number, each graft from that donor receives a numeric graft ID.  Individual grafts from the same donor will have the same base donor ID, but differing numeric graft ID's.  Bacterin's product code and graft ID are placed on the finished product label.
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Bone products are derived from donated cadaver human tissue. They were prepared from tissue procured from a cadaver donor using aseptic surgical techniques.    Each donor receives a Bacterin ID number, each graft from that donor receives a numeric graft ID.  Individual grafts from the same donor will have the same base donor ID, but differing numeric graft ID's.  Bacterin's product code and graft ID are placed on the finished product label.
Fascia product is derived from donated cadaver human tissue. It was prepared from tissue procured from a cadaver donor using aseptic surgical techniques.    Each donor receives a Bacterin ID number, each graft from that donor receives a numeric graft ID.  Individual grafts from the same donor will have the same base donor ID, but differing numeric graft ID's.  Bacterin's product code and graft ID are placed on the finished product label.
Blood products, collected from donors whose arm preparation was inadequate, were distributed.
Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models. Made in China.  Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.    For dental health; plaque removal.
Spinbrush Pro Clean Soft (6687800078) Spinbrush Pro Clean Medium (6687800079)  Spinbrush Pro Clean Replacement Head Soft 2 ct (6687800080)  Spinbrush Pro Clean Replacement Head Medium 2 ct (6687800081)  Spinbrush Pro Clean 3 ct BJs (6687800145)  Spinbrush Pro Clean 2 ct (6687800425)  Spinbrush Pro Clean Extra Soft 2 ct (6687800433)  Spinbrush Pro Clean Combo Pack (6687800461)  Spinbrush Pro Clean Value Pack (6687800466)  Spinbrush Pro Clean Soft Value Pack (6687800709)  Total Spinbrush Pro Clean  Spinbrush Pro Recharge  Spinbrush Pro Clean Recharge (6687800160)  Total Spinbrush
Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life.
Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in China.  Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.    For dental health; plaque removal.
Spinbrush Pro Clean Recharge (6687800160)
Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening Made in China.  Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.    For dental health; plaque removal.
Spinbrush Pro Whitening Soft (6687800191) Spinbrush Pro Whitening Replacement Head Soft 2 ct (6687800192)  Spinbrush Pro Whitening Medium (6687800193)  Spinbrush Pro Whitening Replacement Head Medium 2 ct (6687800194)
Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.    For dental health; plaque removal.
Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush (668780016201)
Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush  Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.      For dental health; plaque removal
Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush (668780016202)
Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush  Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.      For dental health; plaque removal
Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush (668780016400)
Arm and Hammer Spinbrush Pro White Sonic Toothbrush   Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.    For dental health; plaque removal
Arm and Hammer Spinbrush Pro White Sonic Toothbrush (668780016401)
Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS  Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.      For dental health; plaque removal.
Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS (6687800614408)
Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.    For dental health; plaque removal.
Arm and Hammer Spinbrush Pro Clean Sonic Recharge (668780094001)
Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA.    For dental health; plaque removal.
Arm and Hammer Spinbrush Pro Clean Sonic Recharge (668780094002)
Unlicensed blood products were distributed in interstate commerce.
Platelet Pheresis Leukocytes Reduced Irradiated
Red Blood Cells Apheresis Leukocytes Reduced
Approximately two thirds of product went to Denmark, Australia, Canada, and Mexico.  The remaining one third distributed domestically nationwide.
Human semen for intracervical insemination and/or intrauterine insemination.  Vials are labeled with the donor number, date of donation, and ''Seattle Sperm Bank''. Vials that are for intrauterine insemination (IUI-ready) have a green color band indicating it is ready for intra uterine insemination after thawing. Vials that do not have a green band indicate that the semen is an intra cervical insemination sample (ICI).
Human semen, collected from donors that did not have repeat physical exam within 6 months prior to donation, was distributed.
Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07),  b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc.  Woodcliff Lake, NJ  07677 USA, Marketed by: The Medicines Company, Parsippany, NJ 07054 USA
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
Haemonetics MCS+9000 Pump Encoder Automated Blood Cell Separator Model LN 9000
Apheresis Collection Devices, with a possible pump encoder failure, were distributed.
Haemonetics Cymbal Automated Blood Collection  Model LN1900
Worldwide Distribution -- USA, including the state of CA, and country of Canada.
Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version  V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78.   Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm.  When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation.
Human corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Distribution was made to IL, MI, MS, AL, CO, MD, TX, GA, NY, KS, AR, FL, NV, WA, CT, UT, VT, PA, LA, TN, NE, MN and OR.  Foriegn distribution was made to Canada.
Defense Nutrition Warrior Whey Natural Powder, dietary supplement, packaged in 14-oz. bottles and packed 6/14-oz bottles per case.
The products contain undeclared soy lecithin
Defense Nutrition Organic Warrior Whey Powder, Plain, dietary supplement, packaged in 14-oz. bottles and packed 6/14-oz bottles per case. Distributed by Defense Nutrition, Woodland Hills, CA.
Dr. Mercola Miracle Whey Protein Powder, dietary supplement, packaged in 1-lb. bottles and packed 6/1 lb-bottles per case. Distributed by Mercola Health Resources, LLC, Aurora, IL.
Wardley Advanced Nutrition Perfect Protein Tropical Fish Flake Food Net Wt. 1 OZ. (28 g) UPC 0-43324-00591-7 Made in the USA by The Hartz Mountain Corporation Secaucus, New Jersey 07094
Fish food may be contaminated with Salmonella
Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NM, NJ, NY, NV, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA & WI and internationally to  Belgium; Danemark; France; Germany; Isral; Italy; Lebanon; Luxemburg; Netherlands; Norway; Portugal; Saudi Arabia; Spain; Switzerland; Turkey & United Kingdom.
Integra Advansys Medial Lisfranc    Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536   The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthrodesis, Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.
Model #181041S, Batch #s EKU8, EN2D, EN2B, EMOK & EN2B; Model #181051S, Batch #s EJQY, FOSU, ECEB & E179; Model #181041, Batch #s EB1E, EBKY, ECE9, EHA7, E647, E8NP, E8P7, E8ML, E8N5, E8PV, E8N5 & E5GV; Model #181042, Batch #s E648, EB1F, E8MM, E8NQ, E8PW, E5GW, E8N6, E8P8, E5GY, E8PW & EBKZ; Model #181052, Batch #s E5GY, E64A, E8PY, E5GW, E8PA, E8NS, E8N8, E8MP & EB1H; Model #181051, Batch #s E649, E5GX, E8MN, E8N7, E8P9, E8NR, E8PX, ECEB, EJ79, EB1G, EBLO & ECEB; Model #181052S, Batch #s E8PY, EB1H, EB14 & E8MP; Model #181042S, Batch #s E8MM, EB1F & EBKZ.
Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery.
Nationwide including Puerto Rico.  OUS to include:  Abu Dhabi, Argentina, Australia, Brazil, Brunei, Canada, China, Costa Rica, Czechoslovakia, Dominican Republic, Dutch Antilles, Finland, Germany, Great Britain, Greece, Guam, Honduras, Hong Kong, Ireland, Israel, Japan, Korea, Kuwait, Mexico, New Zealand, Pakistan, Panama, Russia, Singapore, South Africa, Sweden, Thailand, and Trinidad.
Kaytee Forti-Diet Pro Health Mouse, Rat & Hamster, with DHA Omega-3 supports Heart, Brain  & Visual Functions.  Nutritionally Enhanced Daily Diet for a long, happier, healthier life.  Packaged into the following sizes and UPC codes. - 3lb (1.36 kg), UPC 71859-99994,  - 5lb. (2.27kg) UPC 71859-00001;   - 25 lb. (11.34 kg) UPC 71859-99995;   and - 25 lb bags for use within Petco stores UPC 71859-00000.  Manufactured by:  Kaytee Products, Inc., Chilton, WI  53014 USA.
Best Before Codes:  30 Mar 2013 (25 lb - Petco stores only), 31 Mar 2013 (25 lb), 31 Mar 2013 K63 (6/3 lb), and 03 Apr 2013 K61 (6/5 lb)
Kaytee Pet Products is recalling a single manufacturing batch of Kaytee Forti-Diet Pro Health Mouse, Rat and Hamster due to possible contamination with Salmonella
Worldwide Distribution -  USA (nationwide) and the countries of Singapore, China, Hong Kong,Canada, Australia, Japan, Europe, Germany, India, and Finland.
Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana    The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Postmarket reports indicate that the spring clip may fracture or fall off of the instrument during use, posing the risk that a device fragment may be left in the surgical site. The risk of disassembly or fracture appears to be happening during use of this instrument where the instrument is typically impacted with a mallet to aid in insertion. The applied forces are contributing to the instrument fractures. The fracture of the spring clip is an unintended use oft he product.  Zimmer initiated a recall of this instrument in March 2011, at which time an updated design to the spring clip for the jaw assembly was implemented due to fractures of the spring clip. Zimmer has received 62 complaints (as of April 25, 2012) for the spring clip fracturing on the updated design.
Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana   The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Part 00-5901-026-40 Lot 62011774, 61870067, and 61813699 Initially the 00-5901-026-40 replacement jaws will remain available for order until all of the alternative instruments are in place, however they will also be required to be returned. The final lot numbers and manufacture dates will be provided in a subsequent status update.
Postmarket reports indicate that the spring clip may fracture or fall off of the instrument during use, posing the risk that a device fragment may be left in the surgical site. The risk of disassembly or fracture appears to be happening during use of this instrument where the instrument is typically impacted with a mallet to aid in insertion. The applied forces are contributing to the instrument fractures. The fracture of the spring clip is an unintended use oft he product.  Zimmer initiated a recall of this instrument in March 2011, at which time an updated design to the spring clip for the jaw assembly was implemented due to fractures of the spring clip.  Zimmer has received 62 complaints (as of April 25, 2012) for the spring clip fracturing on the updated design.
Blood products, collected from a donor who was previously deferred, were distributed.
Blood products, collected using equipment for which quality control was not performed, were distributed.
Red Blood Cells Leukocytes Reduced Washed
Blood products, collected from a donor who traveled to a malaria endemic area, were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products, which did not meet acceptable product specifications, were distributed.
Wellness Complete Health Super5Mix Large Breed Puppy, packaged in:  15 lb. and 30 lb. bags and 5 oz. sample bags  Product Code: 89591   UPC: 4 00 76344 89591 4    Super5Mix Large Breed Puppy 12/5oz;.  Product Code: 89114    UPC: 0 76344 89114 7   Super5Mix Large Breed Puppy 15 lb.;  Product Code: 89115  UPC: 0 76344 89115 4  Super5Mix Large Breed Puppy 30 lb.
Best by dates of JAN 9 2013 through JAN 11 2013.
Product maybe potentially contaminated with salmonella (manufactured by Diamond Pet Foods)
US/Nationwide; Canada, China, Denmark, India, Israel, Japan, Philippines, & Sweden
Capture-R Ready Indicator Cells, with a rate of reported events for equivocal and unexpected positive reactions significantly higher than other lots, were distributed.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
SoftBank II versions 23.1 and 25.1 applications are decision support software devices. SoftBank II versions 23.1 documents the receipt of inventory from an outside source, multi-side inventory control, records the confirmatory testing on the units and allows for records keeping on component preparation for transfusion.
Software, with a glitch or defect, was distributed.
Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ.   The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.
i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer.
JFC International Inc. is recalling Oyster IQF L size Frozen wild, PAFCO Oyster Meat Tiny IQF, Oyster M Frozen Farm, Breaded Oyster Frozen, Tablemark Kaki (oyster) Fry, and Pacific Surf Breaded Oyster Fry.  The products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
Tablemark Kaki (Oyster) Fry, 2/12/6.34 oz.
Pacific Surf Breaded Oyster Fry, 12/2 lbs.
Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA  92880; Distributed by: Watson Pharma, Inc., Corona, CA  92880.
Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, 50 unit dose cups, VISTAPHARM, Largo, FL  NDC 66689-036-50
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
LifeSouth Community Blood Centers Inc - Birmingham Region
Blood product, which did not meet acceptable product specifications, was distributed.
Blood Systems Inc/dba United Blood Services
Blood products, collected using equipment that had not been validated, were distributed.
Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China.
OEC 9800 Plus Digital; MDL number A349855.   Product Usage:  Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures.  Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.  The system may be used for other imaging applications at the physician's discretion.
Part of a total of 82 units distributed.
Please be aware that this is not a new recall.  The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency.  GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm.  The devices were manufactured between October 15, 2004 and December 8, 2004.  This issue could potentially result in the system failing to store images when the hard disk drive capacity exceeds 170 images instead of the expected 400.  Systems may also fail to boot or lose patient data as this image capacity is approached.
OEC MiniView 6800 Mobile; MDL number A349855.   Product Usage:  The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging.  The device is not intended for whole body pediatric imaging.
UroView 2800; MDL number A349855.   Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.  Clinical application may include but are not limited to urologic and endoscopic procedures.  The system may be ued for other imaging applications at the physician's discretion.
Product was released for distribution in HI.
Aloha Maid Natural brand Coconut Water with Pineapple in 11.5 fl oz (340mL) Can; UPC Code: 8-35146-00818-3; 24 cans per case (4 packs X 6 cans each) Product is processed and packaged by ITO EN (USA) INC., Honolulu, Hi
The drink can is stamped on the underside with the code: IHMAY0913XXXX; [XXXX = military time of the day; IH = ITO EN HAWAII; MAY0913 = Expiry code presenting product was produced on May 9, 2012 and will expire on May 9, 2013]
Product has off-smell and off-taste and should not be consumed.
Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.
Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models:  Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1).    Product Usage:  To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.
Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm.
CA, OH and NY to retail stores and restaurants.
Multiple lots of cheese produced by Andante Dairy, Petaluma, CA; Sold in 5 oz to 8 oz sizes with no code date or variety information on packaged. Varieties include:   Largo, a triple-creme cow's milk, and Picolo, a triple-creme cow's milk.  Also made with cow's milk: Pianoforte, Nocturne.  Goat's milk cheese varieties: Acapella, Impromptu, Pastoral, Fresh Goat and Crottin,  Minuet, a triple-creme goat's milk variety.  Mixed Milk cheese varieties: Rondo, Metronome, Melange.  Other varieties include Cavatina, Contralto, Vivace, Partita, Tri, Mini Alto, Figaro,Cadence
Lack of proper pasteurization could have allowed dangerous pathogens to survive in multiple lots of cheese.
Sunquest Laboratory Blood Bank and Blood Donor
Sunquest Blood Bank and Blood Donor versions: Sunquest Blood Bank and Blood Donor versions 6.0.1 Distributed with Sunquest Laboratory 6.1; 6.0.1 Distributed with Sunquest Laboratory 6.2; 6.0.2 Distributed with Sunquest Laboratory 6.3; 6.4 Distributed with Sunquest Laboratory 6.4
Stryker Instruments Div. of Stryker Corporation
Worldwide Distribution - US Nationwide and the countries of   England, France, Netherlands, and Switzerland.
RF Cannula, 100 mm,Curved  5 MM, 20 G,  REF 0406-630-115 RX only, Disposable ( 10/pk)   Product Usage:  The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic, spinal, and neurosurgical applications.
Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package.  If the clinician does not recognize that the active tip on the cannula is 10 mm instead of 5mm and the cannula is used in a cervical procedure there is a potential for a thermal skin lesion due to a larger lesion creation.  If the 10 mm active tip cannula, as opposed to the 5mm active tip, is placed perpendicular to the target on a very thin patient, there is a potential for the patient to be exposed to skin burn.
RF Cannula, 100 mm,Curved  10 MM, 20 G,  REF 0406-630-125 RX only, Disposable ( 10/pk)   Product Usage:  The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic, spinal, and neurosurgical applications.
Worldwide Distribution - US (nationwide) and the countries of  Australia, Belgium, Brazil,  Egypt, France,  Germany, Netherlands, Norway, Saudi Arabia,Switzerland,
Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010    Product Usage:  The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.
Serial Numbers: 20210001 through 20210078
Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT
Beekley S-Spots Floral Skin Markers -Order Number: 750   Product Usage:  Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
Digital Skin Mammography Marker  separating from the backing of the spot material
Beekley A-Spots Floral Skin Markers -Order Number: 751   Product Usage:  Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
Beekley O-Spots Floral Skin Markers -Order Number: 752   Product Usage:  Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
Beekley Altus Floral Skin Markers -Order Number: 754   Product Usage:  designed for Digital Mammography-Disposable skin markers for marking  areas of concern or pain
Nationwide Distribution includingArizona, California, Ohio, Pennsylvania and Virginia.
Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL.    DIANEAL Low Calcium peritoneal dialysis solutions are indicated for use in chronic renal failure patients being maintained on peritoneal dialysis. - and- The Personal Cycler Peritoneal Dialysis System [cycler and ancillary sets] is used for automatic control of dialysate solution exchanges in treatment of renal failure patients undergoing peritoneal dialysis. The Personal Cycler System automatically cycles a prescribed volume of dialysis solution into and out of the peritoneal cavity during the dialysis treatment.
Baxter discovered that a Baxter technical service representative was providing incorrect instructions for inspection of solution bags for a blocked frangible prior to connection to the Automated PD Set with Cassette.
High Pressure Stopcock (3-Way, Luer Lock, Off).   Product Usage:  For IV.
The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.
Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets   Product Usage:  For waste managment.
94'' (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
Flush Kit w 3 Way Off Stopcock   Product Usage:  Flush Kit
Part Number AG8137 510(k) K052865  Lot number 2466161
Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.
INSTRUMENT ARM DRAPE IS2000, 20 PACK:        Product Usage:  The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK;        Product Usage:  The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK;        Product Usage:  The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK;        Product Usage:  The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK;           Product Usage:  The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
ACCESSORY BASE STARTER KIT,IS3000;           Product Usage:  The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
IRISpec'' CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074.   Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert.  For in vitro diagnostic (IVD) use only.
Iris Diagnostics part number 800-0074, lot number 131-12.
The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which should be positive.
Florida, Georgia, Alabama, Mississippi, Louisiana
Winn-Dixie Cheeseburger Macaroni Skillet Dinner WD Code  202410, Size 5.8 oz
Potentially contains small metal fragments
Worldwide Distribution - USA including FL, MO, MA, AL, KY, IN, NC, LA,PA, VA, OH, NY, ME, MI, TX, KS, TN, OK, NJ, WA, CO, GA, CA, MN, IA, OR, and IL and Internationaly to Austria, Luxenbourg, Sweden, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo.
Equinoxe Anatomic Replicator Plate   Intended for Primary and Reverse Total Shoulder Arthroplasty
Sizes:  1.5 mm: Catalog Number 300-10-15 Serial Range 1653131-2381151    4.5 mm: Catalog Number 300-10-45 Serial Range 1622046-2381151
54,877 units for all products in Recall Event
Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year shelf life.
Equinoxe Fixed Angle Replicator Plate   Intended for Primary and Reverse Total Shoulder Arthroplasty.
Size: 0mm Catalog Number: 300-25-00  Serial Range: 1999574-2381151
Equinoxe Reverse Compression Screw   Intended for Primary and Reverse Total Shoulder Arthroplasty.
Equinoxe Reverse Shoulder Fracture Adapter Tray Screw   Intended for Primary and Reverse Total Shoulder Arthroplasty.
Catalog Number 324-11-00  Serial Range 1653706-2381151
Equinoxe Reverse Glenosphere Locking Screw   Intended for Primary and Reverse Total Shoulder Arthroplasty.
Catalog Number 324-15-05 Serial Range 1620549-2381151
Octane-C Cervical, 6 Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
Sizes:  5 mm Catalog # 05-010-02-0605 All serial numbers  6 mm Catalog # 05-010-02-0606 All serial numbers  7 mm Catalog # 05-010-02-0607 All serial numbers  8 mm Catalog # 05-010-02-0608 All serial numbers  9 mm Catalog # 05-010-02-0609 All serial numbers  10mm Catalog # 05-010-02-0610 All serial numbers  11mm Catalog # 05-010-02-0611 All serial numbers  12mm Catalog # 05-010-02-0612 All serial numbers
Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9
Presence of Particulate Matter:  Lots identified in this recall notification may contain small particulates.
Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Germany, Denmark, Spain, France, Hong Kong, Ireland, Israel, India, Italy, Japan, South Korea, Netherlands, Poland, Russia, Saudi Arabia, Sweden, Singapore, and Thailand.
Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16   The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment.
As a result of a small number of customer complaints, MAQUET conducted an investigation and identified a potential problem with specific MAGNUS Carbon-Fibre Table Tops manufactured between February 23, 2010 and February 28, 2012 and distributed between November 11, 2010 and April 6, 2012.  There is a potential issue with the motor brakes for the longitudinal shift drive, and the tilt drive.
Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg,  500 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-340-05
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.
Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-127-05
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets
Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle,  Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10.
Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks.  The same complainant also reported that metal shaving like material was observed on the surface of one tablet.
The Wright Group dba Wright Enrichment, Inc.
WE-24541 Vit/Min Premix Toddler (1-4 yr old) w/o DHA*ARA, NET WEIGHT 22.68 KG
The product contains Galactooliosaccharide which was recalled due to possible salmonella contamination.
Retail stores, truck stops, Vending facilities in the Monroe Michigan Area.
Spillson's Texas BBQ Beef Sandwich, 4 oz.
Undeclared soy and wheat found in the flour ingredient of the Texas BBQ Beef sandwich. People with an allergy or sensitivity to soy or wheat run the risk of a serious or life threatening reaction if they consume this product.
Spillson's Ltd. Bologna & Cheese Sandwich, Nt. Wt. 4 oz
Undeclared wheat found in the flour ingredient, undeclared soy lecithin in cheese product.  People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product.
Spillson's Ltd. The Big Sicilian Sandwich Nt. Wt. 7oz
Undeclared yellow # 5 found in the sandwich pepper ingredient.   People with a sensitivity to yellow # 5 run the risk of a serious or life threatening reaction if they consume this product.
Spillson's Ltd. Ham Sandwich Nt. Wt. 7 oz
Undeclared wheat found in the sandwich flour ingredient and undeclared soy lecithin in the cheese ingredient.  People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product.
Spillson's Ltd. Meatball Sub Sandwich Nt. Wt. 10 oz
Undeclared wheat found in the sandwich flour ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product.
Spillson's Ltd.Greek Pita Sandwich Nt. Wt. 7oz.
Spillson's Ltd. Smoked Turkey & Swiss Pita Sandwich, 7 oz.
Undeclared wheat found in the sandwich flour ingredient. Undeclared soy lecithin in the Cheese ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product.
Spillson's Ltd. Ham & Swiss Pita Sandwich, 7 oz.
Undeclared wheat.  People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product.
Spillson's Ltd. Ham & Turkey Combo Sandwich, 9 oz.
Undeclared wheat and soy not declared as source of the lecithin ingredient. People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product.
Spillson's Ltd. Sausage & Egg Muffin Sandwich, 6oz.
Sandwich contains undeclared wheat in flour ingredient and undeclared soy lecithin in cheese ingredient.  People with an allergy or sensitivity to wheat  or soy run the risk of a serious or life threatening reaction if they consume this product.
Sandwich contains undeclared wheat in flour ingredient .  People with an allergy or sensitivity to wheat  run the risk of a serious or life threatening reaction if they consume this product.
Spillson's Ltd. Roast Beef Sandwich 97% Fat Free, 7oz.
Sandwich contains undeclared wheat in flour ingredient and undeclared soy lecithin in the cheese ingredient.  People with an allergy or sensitivity to wheat  or soy run the risk of a serious or life threatening reaction if they consume this product.
Spillson's Ltd. Super Italian Sandwich , 10 oz.
Sandwich contains undeclared wheat in flour ingredient, undeclared yellow #5 in the pepper ingredient.  People with an allergy or sensitivity to wheat  or soy run the risk of a serious or life threatening reaction if they consume this product.
Sandwich contains undeclared wheat in flour ingredient.  People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product.
Sandwich contains undeclared soy lecithin found in the cheese ingredient.  People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product.
Spillson's Ltd. Double Cheeseburger Sandwich.
Spillson's Ltd. Breakfast Muffin Sandwich, 6 oz  Ham
Sandwich contains undeclared wheat found in the flour ingredient and undeclared soy lecithin found in the cheese ingredient.  People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product.
US Nationwide Distribution - including the states of CO, OH, OK and TX.
Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US)   Product Usage:  The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient
4 degree - SJ768T-US and 9 degree SJ780T-US
The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but the part number etched on the instrument may be incorrect.  The 4 degree trial instrument (SJ768T-US) may be marked with the incorrect part number of the 9 degree trail instrument (SJ780T-US) and the 9 degree trial instrument (SJ780T-US) may be marked with the incorrect part number of the 4 degree trial instrument (SJ768T-US).  The incorrect etching was not identified at final inspection.
All lots were distributed throughout the US.
Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ  07724 USA under the labels a) NOVAPLUS (NDC 0143-9704-25), b) West-Ward (NDC 0143-9788-25).
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ  07724 USA under the labels a) NOVAPLUS (NDC 0143-9703-10), b) West-Ward (NDC 0143-9782-10).
Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR PHARMACEUTICALS, Livonia, MI --- NDC 0904-5255-30,
Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging.  Package incorrectly states 5/2014 should correctly state 4/2014
OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only, Manufactured for: Cadence Pharmaceuticals, Inc., San Diego, CA  92130, NDC 43825-102-01, UPC 3 43825 10201 7.
Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.
Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin.
Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
Crispy Just Baked Punjabi Cookies sold in 800 gr clamshell packages.   Manufactured by :  TWI Foods, Inc., Mississauga, ON, Canada.
FDA was notified of a recall by CFIA for Punjabi Cookies manufactured by TWI Foods, Canada that may not declare milk as an ingredient.