HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial,  plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only   To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
CGMP Deviations: Incomplete documentation associated with test results.
HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial,  plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505;  Rx only   To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Product Code 504501 (1 mL): Lot 406912 (Expiration Date  01/11) and Lot 408072 (Expiration Date 09/11);  Product Code 504505 (5 mL): Lot 406914 (Expiration Date 01/12)
Product Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials
Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00
PTC Drug Number: 4033.  PTC Batch Number: 65IT.  Batch Date: 10/13/2010.  Expiration Date: 11/30/2011.  NDC: 54868-4033-00
540 tablets (9 containers of 60 tablets each)
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Morphine Sulfate Immediate Release tablet, 30 mg/120 tablet bottles, Rx only,   Physician Total Care, Inc, Tulsa, OK 74146-6234, NDC 54868-4973-00
PTC Drug Number: 4973.  PTC Batch Number: 65J2.  Batch Date: 10/13/2010.  Expiration Date: 06/30/2012.  NDC: 54868-4973-00
600 tablets (5 containers of 120 tablets each)
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections.    Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
Two reasons for recall.   1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health.     2. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution - US(nationwide) and the countries of: Brazil, Canada, Columbia, Italy, Lebanon, Spain, Switzerland, and UK.
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection.  .     Product is labeled in part: ''***Certain 3.25, 13***REF IOSM313  LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile***RX only Caution: Law prohibits dispensing without prescription***do not use if package is damaged***do not reuse***consult instructions for use***Sterile unless package is opened or damaged.***    Product Usage:  The BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means of prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model  # IOSM313, Lot #2010111529. Dental implant lot may not have an internal thread.
Product was shipped to the following states: IL, IN, KY, OH, TN & VA.
Salsa in 12 oz., 16 oz., and 5 lb. plastic containers.  The product labels reads as follows: PREMIUM QUALITY Private Selection Natural***SALSA NO PRESERVATIVES KEEP REFRIGERATED NET WT 12 OZ (340g)***INGREDIENTS: Tomatoes***Jalapeno***DISTRIBUTED BY: INTER-AMERICAN PRODUCTS, CINCINNATI, OHIO 45202***1-800-697-2448***'' and PREMIUM QUALITY Private Selection Natural PICO DE GALLO NO PRESERVATIVES KEEP REFRIGERATED NET WT 12 OZ (340g)***INGREDIENTS: Tomatoes***Jalapeno***DISTRIBUTED BY: INTER-AMERICAN PRODUCTS, CINCINNATI, OHIO 45202***1-800-697-2448*** and heinens'' Fresh***Salsa All Natural Net. Wt. 16oz. (1lb) 454g***Ingredients: Tomatoes***Jalapeno***PACKED FOR HEINENS BY CLUB CHEF, LLC and heinens'' Fresh Bruschetta All Natural Net. Wt. 16oz. (1lb) 454g ***Ingredients: Tomatoes***Jalapeno***PACKED FOR HEINENS BY CLUB CHEF, LLC
Private Selection Brand: PICO DE GALLO-UPC# 11111091135, HOT SALSA-UPC# 1111091139 & MILD SALSA-UPC# 1111091137; heinen's brand: HOT SALSA-UPC# 2060100024 & MILD SALSA-UPC# 2060100026.  Both brands have Use By 3/27/12.
South Florida Produce of Boynton Beach in Florida shipped fresh jalapeno peppers to Castellini Company in Wilder Kentucky.  Castellini shipped the peppers to a store in Ohio, where the Ohio Department of Agriculture collected a sample of these peppers which subsequently were found contaminated with Salmonella.  This same lot of fresh peppers was shipped to Club Chef which manufactured the Salsa which is under recall and identified in this Recall Enterprise System document.
''***Queso Blanco del Pais***TRIDAS***Receta Original***''
PR State Department sampling found  positive results for Clostridium Clostridioforme
''***Queso del Pais***TRIDAS***Pasta y Queso ''Guayaba''***''
''***Queso del Pais***TRIDAS***Pasta y Queso ''Mango''***''
Nationwide Distribution-including the states of AL, FL, GA, MO, and VA.
GE Healthcare, Aestiva/5 7900 SmartVent'', anesthesia machine, GE Healthcare P.O. Box 7550 Madison, WI 53707-7550.   This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. User interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional). This device is to be used only by trained and qualified medical professionals
Serial Number AMRP01031  AMRP00966  AMRP01030  AMRP00968  AMRP00967  AMRP01033  AMRP00970  AMRP00969
GE Healthcare has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of your Aestiva 7900 Anesthesia Device. This Potential for two (2) vaporizers delivering agent at the same time.  This could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent.  This may cause prolonged or persistent hypotension requiring medical intervention.  To date, no injury has been reported to GE Healthcare associated with this issue.
PrepStain Syringing Pipettes 240 (Catalog #490517)
46,112,784 for all products in Recall Event
The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes
PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)
Nationwide Distribution including the states of CO,  IN, and MN.
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
Software Version 3.1.1 does not meet navigational accuracy.
Worldwide Distribution-USA (nationwide) including the states of  AL , AR , AZ, CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , MD , ME , MI , MI , MN , MO , MT , NC , ND , NE , NH , NJ , NM , NV , NY , OH , OK , OR , PA , RI , SC , SD , TN , TX , UT , VA , WA , WI, and WY and the countries of  Australia, Belgium, Brazil, Canada, Chile, Germany, Honduras, Hong Kong, India, Japan, Mauritius, Nicaragua, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates  (UAE), and Vietnam.
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8'' CONNECTOR, 7.5'' (19 CM) LONG.   The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the particulate is still undetermined and while Terumo CVS has no other documented instances of this substance appearing during production, it has determined that any unit manufactured within the last three years on the same mold could potentially be affected.  The particulate can be dislodged from the connector surface and either adhere to the gloves of the clinician in the sterile field, or fall into the pericardial well while the surgeon is connecting the cannula to the arterial line of the cardiopulmonary bypass circuit.
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8'' CONNECTOR, 11'' (28 CM) LONG.   The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8'' CONNECTOR, 11'' (28 CM) LONG, WITH XCOATING SURFACE COATING.   The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8'' CONNECTOR,SUTURE RING, 9.5'' (24 CM) LONG.   The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8'' CONNECTOR,SUTURE RING, 9.5'' (24 CM) LONG.   The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8'' CONNECTOR,SUTURE RING, 9.5'' (24 CM) LONG.   The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8'' CONNECTOR, CM MARKING, 10'' (25 CM) LONG.   The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
24FR FLEX ART CANN NON STERILE.    The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
SPECIALTYCARE - HUDGENS.   The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Catalog number: 64625 and Lot code: NA17, NC07A, NG06, NG06A, and NL19.
CUSTOM CPB CATHETER KIT-DR.   The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Catalog number: 80001-01 and Lot code: MG21, MM04, NA24, ND21, NK01, NM31, and PA30.
CPB CATHETER KIT- DR.VAN TRIGHT.   The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
Catalog number: 80004-02 and Lot code: MG07, MK02, MM11, MN15, MP13, ND28, NE25, NN21, and PA23.
Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.
Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots.   Product Usage:  The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test.  Currently the VerifyNow P2Y12 Test reports three values:  PRU, BASE and % Inhibition.  The change implemented is the elimination of the BASE and % Inhibition results.  There will be no change to the reporting of the PRU result which will be the only value reported.
VerifyNow System, part #85005-6H   Product Usage:  The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
Worldwide Distribution-USA (nationwide) and the countries of  ALBANIA, ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BULGARIA, CAMBODIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ENGLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COAST, JAPAN, KAZAKHSTAN, KINGDOM OF SAUDI ARABIA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NAMIBIA, NEPAL, NEW ZEALAND, NIGERIA, PAKISTAN, PERU, PHILIPPPINES, PORTUGAL, REPUBLIC OF CHINA, REPUBLIC OF SOUTH AFRICA, RUSSIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH AUSTRALIA, SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, THE NETHERLANDS, TOGO, TUNISIA, TURKEY, UGANDA, UNITED ARAB EMIRATES,  and VIETNAM.
NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W.   Oxygen Concentrator.
Serial numbers 042-10000 through 102-07044
Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W.   Oxygen Concentrator.
NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W.   Oxygen Concentrator.
NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W.   Oxygen Concentrator.
NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W.   Oxygen Concentrator.
NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W.   Oxygen Concentrator.
NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W.   Oxygen Concentrator.
NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W.   Oxygen Concentrator.
NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W.   Oxygen Concentrator.
Product was released for distribution in US and Canada.
Casa de Mesquite brand Mesquite Bean Flour, packaged in 10 kg bag in carton, and 13 kg bag in carton for food manufacturing, and 10, 24 and 44 oz retail bags; Product is processed and packaged by Casa de Mesquite, LLC, Hollister, CA
Recent tests show that one lot of this product has the potential to be contaminated with bacillus cereus, a spoilage organism which can cause diarrhea, nausea and other symptoms.
US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700.     Ever-Rest US Brochure US-001 Rev A.   Brochure:  ''***AT acceleration THERAPEUTICS***At Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research...***Whole Body Periodic Acceleration (WBPA) therapy has been demonstrated to naturally activate the release of beneficial mediators like Nitric Oxide (NO) throughout the vasculature.***Nitric Oxide [NO] supports the functioning of endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow through arteries and veins.  With age arterial production and availability of Nitric oxide declines.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***info@nims-inc.com www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***US-001 Rev A***''    Printed marketing brochure
Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700.       Brochure:  ''EXER-REST***A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaints***Whole Body Periodic Acceleration (WBPA)***WBPA is accomplished utilizing the Ever-Rest device to move the body repetitively head to foot at approximately 140 times a minute.  This repetitive motion adds pulses to your natural vascular pulse with each acceleration and deceleration of the body.  These additional pulses act on the inner lining of blood vessels (endothelium) throughout the body, a process called pulsatile shear stress, to promote the release of beneficial substances (mediators).  These mediators, such as nitric oxide, provide a wide range of health benefits that originate from the user's own body.***Nitric Oxide (NO) is released from endothelial cells that line the arterial walls.  NO signals vascular smooth muscle to relax, thereby increasing blood flow throughout the circulation.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***info@nims-inc.com www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***USA-002 Rev A***''    Printed marketing brochure
Philips Easy Diagnost   Product Usage:  Stationary Fluoroscopic system
All systems with Eleva software version 4.x and stitching option.
If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected.  As a result of this, a surgical intervention may be executed unnecessarily. Usability is identified to be the main contributing factor.
Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05
CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
Distributed to retail markets in Northern California.
Santos Brand, Bulgar Wheat, flour packed in clear plastic bags, 2 lbs.
There is no UPC code/lot code/expiration date on products.
The recall was initiated after it was discovered during a routine inspection that the products i.e. various kinds of flours, legumes and spices were cross packaged on shared equipment with peanuts and wheat flour.  The products i.e. various kinds of flours, legumes and spices were distributed in packaging that did not reveal the presence of peanuts or wheat, but may contain traces of it.
Santos Brand, All Purpose flour packed in clear plastic bags, 2 lbs, 5lbs
Santos Brand, Cinnamon Sticks packed in clear plastic bags, 7oz, 14oz
Santos Brand, Cumin Seeds packed in clear plastic bags, 7 ounces, 14 ounces, 2 pounds
Santos Brand, Fennel Seeds packed in clear plastic bags, 3.5 ounces, 7 ounces, 14 ounces, 2 pounds
Santos Brand, Deggi Mirch (Red Capsicum & Kashmiri Red Chile Powder) packed in clear plastic bags,  7 ounces, 14 ounces, 2 pounds
Santos Brand, Garam Masala (Indian Spice Mix) packed in clear plastic bags,  7 ounces, 16 ounces
Santos Brand, Ginger Powder packed in clear plastic bags,  7 ounces, 14 ounces, 2 pounds
Santos Brand, Cardamom packed in clear plastic bags,  3.5 ounces, 7 ounces
Santos Brand, Whole Mace packed in clear plastic bags,  3.5 ounces, 7 ounces
Santos Brand, Mustard Seeds packed in clear plastic bags,  3.5 ounces, 16 ounces
Santos Brand, Urid Split (Lentils) packed in clear plastic bags, 2 pounds, 4 pounds
Santos Brand, Suji (Farina) packed in clear plastic bags, 2 pounds
Santos Brand, garbanzo beans packed in clear plastic bags, 2 pounds, 4 pounds
Worldwide to: Canada and nationwide to: retailers and foodservice distributors in California, Oregon, Washington, Arizona, Idaho, Texas, Illinois, Michigan, Arkansas, Ohio, Tennessee, New Jersey, Georgia, and Florida.
Diced Red Onions, 7oz clear plastic clamshell labeled Gills Onions with the May 17, 2012 use by date,     United States UPC 6 43550 00041 2.    Fresh Diced Red Onions, Oignons rouges frais, en des, 198 grams, Canadian UPC 6 43550 00045 0.
The recall was initiated because Gills Onions, LLC  was informed by FDA of lab results from the Canadian Food Inspection Agency that diced red onions with lot # 51RDA1A2119 may be contaminated with Listeria monocytogenes.
Worldwide Distribution - US (nationwide) including the states of Nevada and Vermont, and the countries of AUSTRALIA, AUSTRIA, CANADA, CYPRUS, GERMANY, ICELAND,  ISRAEL, POLAND, ROMANIA, SOUTH AFRICA, SWITZERLAND, THAILAND, TURKEY and UNITED KINGDOM.
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0.   Product Usage:  The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and patient monitoring. In addition, incorrect QTc values are reported after moving the cursor. QTc values are timing events between labeled points of interest in the ECG signal that the physician can mark with the cursor. The software is used to edit a family of events and upon conclusion the software crashes with an error message.
The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. The software will stop with an error message requiring a restart.  In addition, QTc values will not update after moving the marker.
Distributed only within Ohio.  No Federal Government, foreign or Canadian consignees received product.
LifeGas OXYGEN COMPRESSED UN1072 USP,  Distributed by: Linde
CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill of oxygen cylinders.
Worldwide Distribution - USA (nationwide) and the countries of: Nationwide  Foreign: Canada  AFGHANISTAN  ALBANIA  ALGERIA  ANGOLA  ARGENTINA  ARMENIA  ARUBA  AUSTRALIA  AUSTRIA  AZERBAIJAN  BAHAMAS  BAHRAIN  BANGLADESH  BARBADOS  BELARUS  BELGIUM  BENIN  BHUTAN  BOLIVIA  BOSNIA&HERZEGOVINA  BRAZIL  BRUNEI DARUSSALAM  BULGARIA  BURUNDI  CAMBODIA  CAMEROON  CANARY ISLANDS  CHAD  CHILE  CHINA  COLOMBIA  CONGO  CONGO,DEMOCRATIC  COSTA RICA  COTE D'IVOIRE  CROATIA  CUBA  CYPRUS  CZECH REPUBLIC  DENMARK  DJIBOUTI  DOMINICAN REPUBLIC  ECUADOR  EGYPT  EL SALVADOR  EQUATORIAL GUINEA  ERITREA  ESTONIA  ETHIOPIA  fake test ssd  FINLAND  FRANCE  FRENCH GUIANA  GABON  GAMBIA  GEORGIE  GERMANY  GHANA  GREECE  GUADELOUPE  GUAM  GUATEMALA  GUINEA  GUYANA  HONDURAS  HONG KONG  HUNGARY  ICELAND  INDIA  INDONESIA  IRAN  IRAQ  IRELAND  ISRAEL  ITALY  JAMAICA  JAPAN  JORDAN  KAZAKSTAN  KENYA  KUWAIT  KYRGYZSTAN  LAO PEOPLE'S DEM.REP  LATVIA  LEBANON  LIBERIA  LIBYAN ARAB JAMAHIRI  LIECHTENSTEIN  LITHUANIA  LUXEMBOURG  MACAU  MACEDONIA  MALAWI  MALAYSIA  MALI  MALTA  MARTINIQUE  MAURITANIA  MAURITIUS  METRACOM  MEXICO  MOLDOVA  MONGOLIA  MOROCCO  MOZAMBIQUE  NAMIBIA  NEPAL  NETHERLANDS  NETHERLANDS ANTILLES  NEW CALEDONIA  NEW ZEALAND  NICARAGUA  NIGERIA  NORTH KOREA  NORWAY  OMAN  PAKISTAN  PALESTINE  PANAMA  PARAGUAY  PERU  PHC BEST  PHILIPPINES  PMCC BU Canada  PMCC BU USA  POLAND  PORTUGAL  PUERTO RICO  QATAR  REUNION  ROMANIA  RUSSIA  RWANDA  SAUDI ARABIA  SENEGAL  SERBIA&MONTE NEGRO  SIERRA LEONE  SINGAPORE  SLOVAKIA  SLOVENIA  SOMALIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SRI LANKA  SUDAN  SURINAME  SWEDEN  SWITZERLAND  SYRIAN ARAB REPUBLIC  TAIWAN  TAJIKISTAN  TANZANIA  THAILAND  TRINIDAD AND TOBAGO  TUNISIA  TURKEY  TURKMENISTAN  UGANDA  UKRAINE  Unidentified Country  UNITED ARAB EMIRATES  UNITED KINGDOM   URUGUAY  UZBEKISTAN  VENEZUELA  VIET NAM  YEMEN  ZAMBIA  ZIMBABWE
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon   Stationary Fluoroscopic system
Software release 2.0.2 and 2.0.2SP1 including mirror icon
With Digital Diagnost (DIDI) R 2.0.2 a mirrored ''R in a circle'' is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored ''R in a circle'' appears in the lower left corner. This can be mistaken for a ''right patient side'' marker, although this can appear on the left patient side
Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland
Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531  Inner Pouch:  M00562530 ,    The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
Difficulty in extending snare loop from the catheter
Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551  Inner Pouch:  M00562550    The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571  Inner Pouch:  M00562570    The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
Distributed to retail in the following states: HI, NV, CA
Shiitake-Ya brand Dried Shiitake mushroom slices, 6 oz plastic jars, UPC 7 1452 22183 9. Product labeling reads in part: '' Shiitake-Ya gourmet Shiitake SLICES***Antioxidants Amino Acids Omega 3+6***Immune-Boosting*** NET WEIGHT. 6 oz (170 g)***Natural Enzymes Fiber (80% Chitin) Iron Kojic Acid
Shiitake-Ya Gourmet Shiitake slices are being recalled because FDA test analysis showed presence of pesticide and polycyclic aromatic hydrocarbon residues: 0.208 ppm carbendazim, 0.072 ppm Fluoranthene and 0.092 ppm Pyrene.  There are no tolerances for any of these pesticide residues.
Worldwide distribution:  USA (Nationwide) and countries including; Africa, Argentina, Australia, Belgium, Brazil, Canada, China Costa Rica, CROATIA, Czech Republic,Dominion Republic, ESPAA France, Germany, Greece Guadeloupe, Guatemala, Honduras Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea ,Malaysia, Mexico, Peru, Portugal, Puerto Rico, Spain, Sri Lanka, Switzerland, Taiwan , Thailand, and UK.
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612    The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
LOT #'s BEGINNING WITH THE FOLLOWING  LETTER/NUMBER COMBINATIONS  P7E P8B P8L P9H POE PIB PIL P7F P8C P8M P9J POF PIC PlM  P7G P8D P9A P9K POG PlD P2A P7H P8E P9B P9L POH PIE P2B0153X  P7J P8F P9C P9M POJ PlF P7K P8G P9D POA POK PlG  P7L P8H P9E POB POL PlH P7M P8J P9F POC POM PlJ  P8A P8K P9G POD PIA PlK Also Best Practice Kits Ref#'s: OOZ0800, OOZ0976, OOZ1401, OOZ1407, OOB0117, OOBOI22  NOTE: THE SPECIFIC LOT NUMBERS LISTED BELOW AND LOT NUMBERS  ENDING IN ''''RMX'' and ''RRMX'' ARE NOT AFFECTED BY THIS RECALL  AND ARE ACCEPT ABLE FOR USE. P2A0194XR, P2B0488XR, P2B0153XR
Potential for the sterility barrier to be compromised.
Covidien ROTICULATOR  55-4.8 Single Use Stapler REF# 017614    The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Covidien ROTICULATOR  30-3.5 Single Use Stapler REF# 017615    The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Covidien ROTICULATOR  30-4.8 Single Use Stapler REF# 017617    The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Covidien ROTICULATOR  30-V3 Single Use Stapler REF# 017619    The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Worldwide Distribution -- USA (nationwide) including the states of : AK; AR; AZ; CA; CO; DE; FL; GA; HI; ID; IL; IN; KY; MA; MI; MN; MS; ND; NE; NJ; NY; OH; PA; SC; SD; TN; TX; and WA.  and the countries of : Argentina; Australia; Austria; Canada; Egypt; Germany; Hong Kong; Indonesia; Iran; Italy; Kuwait; Poland; Russia; Saudi Arabia; Singapore; Slovenia; South Africa; South Korea; Spain; Taiwan; Thailand; Turkey; United Arab Emirates; and United Kingdom.
Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE).      The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE.  The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE.    It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling.    The device is labeled in part: ''***OLYMPIC COOL-CAP Cooling Unit***Model No.***Made in USA***Software in this product is Natus Medical Incorporated***''
Olympic Cool-Cap  Cooling Module's power supply failed during treatment. The power supply failure can happen without prior indication and results in the unavailability of the system to begin or continue cooling treatment.
Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446
Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15.  This dye is not approved for use in food, drugs or cosmetics.
AZ, CA, DE, FL, GA, MD, MI, MN, NJ, NY, NC, OR, TX, UT, VA, WA.
Oskri, Peach Granola, Gluten Free, Nut Free, Dairy Free, Vegan, Halal, Kosher, Ingredients: Buck Wheat , Peaches 20% Sunflower Seeds , Apricots, Date Syrup, Chicory Root extract, Rice protein.,  NET WT 3.5oz (100) G., UPC 66616111743,  Oskri, Lake Mills, Wisconsin 53551.
Oskri is recalling one lot of 3.53 oz bags of Peach Granola due to cashews being added to this product in error.
Ocean Group is recalling tiny IQF oysters, large IQF oysters, and half shell oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
AZ, CA, MN, NV, NC, OR, IL, IN, MO, NE, OH, PA, TN, TX, WI.   CANADA, CHILE
KERRY, 4 CHEESE SEAS 30506103, CONTAINS MILK, Net Wt 50 Lb (22.68 Kg), Item Number 30506103.465
Kerry has decided to voluntarily recall its lactic acid containing products because they are contaminated with  metal fragments.
KERRY, WHITE CHEDDAR SNACK SEASONING, CONTAINS MILK, Item Number 6000654.01, Net Wt 50 Lb (22.68 Kg)
KERRY, CREAMY PARMESAN SEASONING, CONTAINS MILK, Item Number 62310.01, Net Wt 50 Lb (22.68 Kg)
KERRY, CHEDDAR CHEESE, CONTAINS MILK, 701183, R-SE-0056 , Item Number 701183.465, Net Wt 50 Lb (22.68 Kg)
KERRY, NACHO SEAS 0686,  Contains Milk, Wheat, Net Wt  22.68 KG (50 lb),   Item Number 10686.482
KERRY, CHEESE BLEND 77,  1150020, CONTAINS MILK AND SOY, Item # 17980.465,  Net Wt 50 Lb (22.68 Kg)
KERRY, PARM. LING. 5734,  SEA 5734, CONTAINS MILK, Item # 15734.607, ,  Net Wt 1000 Lb (453.556 Kg)
KERRY, LASAGNA SKLT SEAS 10078, SE10078,  CONTAINS MILK,  Item # I10078.859,  Net Wt 1600 Lb (725.69Kg)
KERRY, CHEDDAR & SOUR CREAM 1037, CONTAINS MILK,  Item # 717519.360,  Net Wt 25 Lb (11.34Kg)
KERRY, THREE CHEESE MINI SHELLS 10109, CH10109 , CONTAINS MILK, CH718592 Item Number I10109.859,  Net Wt 1600 Lb (725.69 Kg)
KERRY, PARMESAN ASIAGO TYPE SEASONING, CONTAINS MILK, Item # 718622.465,  Net Wt 50 Lb (22.68 Kg)
KERRY, CHEDDAR & SOUR CREAM 725775, CONTAINS MILK, Item # 725775.465,  Net Wt 50 Lb (22.68 Kg)
KERRY, SOUR CR 7 CHIVES 718948, S37ASC, CONTAINS MILK, WHEAT, Item # 718948.465,  Net Wt 50 Lb (22.68 Kg)
KERRY, THICK & CHEESY 0601, CH0601, CONTAINS MILK, Item Number 10601.859,  Net Wt 1600 Lb (725.69 Kg)
Kerry, NO MSG CHED SC SEAS 01113, CONTAINS MILK, Item # 720061.465,  Net Wt 50 Lb (22.68 Kg)
Kerry, PARMESAN BLEND 720068 CH720068, CONTAINS MILK, WHEAT, Item # 720068.607,  Net Wt 1000 Lb (453.556 Kg)
Kerry, CREAMY PARMESAN SEAS S57CP, CONTAINS MILK, WHEAT, Item # 720104.465,  Net Wt 50 Lb (22.68 Kg)
Kerry, CREAMY ITALIAN SEASONING S57CIT, CONTAINS MILK,  Item # 720109.465,  Net Wt 50 Lb (22.68 Kg)
KERRY, CHEDDAR BROCCOLI SEAS S25CBROC, CONTAINS MILK,  Item # 720175.465,  Net Wt 50 Lb (22.68 Kg)
KERRY, CREAMY GARLIC 720721 S25CG, CONTAINS MILK, SOY, WHEAT,  Item # 720721.465,  Net Wt 50 Lb (22.68 Kg)
KERRY, PARM GARLIC 720850 R-SE-0152, CONTAINS MILK,  Item # 720850.470,  Net Wt 50 Lb (22.68 Kg)
KERRY, BACON 7 RANCH SEAS 720943 SE720943, CONTAINS MILK, SOY, WHEAT,  Item # 720943.859,  Net Wt 1600 Lb (725.69 Kg)
KERRY, STROGANOFF SEAS 10079 SE10079, CONTAINS MILK, WHEAT,  Item # I10079.859,  Net Wt 1600 Lb (725.69 Kg)
KERRY, NACHO SEAS NAT, CONTAINS MILK,  Item # 721108.465,  Net Wt 50 Lb (22.68 Kg)
KERRY, WHITE CHEDDAR SEAS 10230 SE10230, CONTAINS MILK,  WHEAT, Item # I10230.859,  Net Wt 1600 Lb (725.69Kg)
KERRY, BUFFALO WING SEASONING  ,  Item # I10256.465,  Net Wt 50 Lb (22.68 Kg)
KERRY, CULTURED NF BUTTERMILK 986, CODE 031001.010,  CONTAINS MILK,  Item # I2868.465 ,  Net Wt 50 Lb (22.68 Kg)
KERRY, MELOBLEND 2237 code: d 1.29 edible, CONTAINS MILK, Item # I7097.465,  Net Wt 50 Lb (22.68 Kg)
KERRY, BUTTERMILK 987 CONTAINS MILK,   Item # I2993.465,  Net Wt 50 Lb (22.68 Kg)
KERRY, AU GRATIN SEAS 722912, CONTAINS MILK, WHEAT,  Item # 722912.465,  Net Wt 50 Lb (22.68 Kg)
KERRY, ONION RING SEAS 18125 , CONTAINS MILK,  Item # B18125.01,  Net Wt 50 Lb (22.68 Kg)
KERRY, STROGANOFF SEAS 722920 SE722920, CONTAINS MILK, WHEAT,  Item # 722920.859,  Net Wt 1600 Lb (725.69 Kg)
KERRY, MAC 7 CHS SAUCE MIX 723357 CH723357, CONTAINS MILK, WHEAT,  Item # 723357.859,  Net Wt 1600 Lb (725.69 Kg)
KERRY, BACON RANCH SEAS 723951 S57RB, CONTAINS MILK, Item # 723951.465,  Net Wt 50 Lb (22.68 Kg)
KERRY, SALSA FRESCA 725058,  Item # 725058.465,  Net Wt 50 Lb (22.68 Kg)
KERRY, ITALIAN PASTA SALAD SEASONING,  Item # 725445.859,  Net Wt 1600 Lb (725.69 Kg)
KERRY, GOLDEN CHEDDAR CHEESE 716932 ,  R-SE-0132, CONTAINS MILK, Item # 716932.465,  Net Wt 50 Lb (22.68Kg)   KERRY, R-SE-0132TM, CONTAINS MILK, Item # 716932.TM,  Net Wt 50 Lb (22.68Kg)
KERRY, MOZZARELLA SESONING - NO PHSO, CONTAINS MILK, SOY, Item # I10187.465 ,  Net Wt 50 Lb (22.68Kg)
KERRY, ROASTED GARLIC SEAS 10112, S37RG2  , CONTAINS MILK, SOY, Item # I10112.465,  Net Wt 50 Lb (22.68Kg)
KERRY, DOUBLE CHEESEBURGER SEAS 8917 , S20DC, CONTAINS MILK, WHEAT, Item #I8917.465,  Net Wt 50 Lb (22.68Kg)
KERRY, SOUR CRM & CHIVES 0989 S37SCC, CONTAINS MILK, , Item #I0989.465 ,  Net Wt 50 Lb (22.68Kg)
KERRY, CHEESEBURGER SEAS 8543, S20C3, CONTAINS MILK,WHEAT , Item #I8543.465 ,  Net Wt 50 Lb (22.68Kg)
KERRY, KF PART # 117404 , CONTAINS MILK, Item #I10389.02 ,  Net Wt 50 Lb (22.68Kg)
KERRY, KF # 11605R, CONTAINS MILK, Item #B18648.02 ,  Net Wt 50 Lb (22.68Kg)
KERRY, KF # 10987R, CONTAINS MILK, Item #B16903.01, Net Wt 50 Lb (22.68Kg)
KERRY, CHEDDAR BEER TYPE 725554 , CONTAINS MILK, Item #725554.465,  Net Wt 50 Lb (22.68Kg)
KERRY, BATTER G3668, 1520374, CONTAINS MILK AND WHEAT, Item #G3668.MC1,  Net Wt 50 Lb (22.68Kg)
KERRY, HOT CHEESE, SEAS, 04-20200,  CONTAINS MILK ,  Item #I10185.465,  Net Wt 50 Lb (22.68Kg)
KERRY, NACHO SEASONING 717379, 04-20200,  CONTAINS MILK , SOY, Item # 717379.465,  Net Wt 50 Lb (22.68Kg)
KERRY, CHEESE BLEND 862B , CONTAINS MILK Item # I2065.465,  Net Wt 50 Lb (22.68Kg)
KERRY, CHEESE SEASONING 15704, CONTAINS MILK,  Item # B15704.01,  Net Wt 50 Lb (22.68Kg)
KERRY, CHEESY CHEDDAR SEAS I10103, CONTAINS MILK, SOY,  Item # I10103.465,  Net Wt 50 Lb (22.68Kg)
KERRY, JALAPENO CHEDDAR 16975, GCAS# 95546689, CONTAINS MILK,  Item # B16975.01,  Net Wt 50 Lb (22.68Kg)
KERRY, MELOBLEND 737, CODE:QO-05358, CONTAINS MILK,  Item # I7126.465,  Net Wt 50 Lb (22.68Kg)
KERRY, PL BROC & CHEESE SEAS 8893 , CONTAINS MILK,  WHEAT, Item # I8893.465,  Net Wt 50 Lb (22.68Kg)
KERRY, MELOBLEND 1048, 95317, CONTAINS MILK,  Item # I7067.465,  Net Wt 50 Lb (22.68Kg)
KERRY, PARMESAN  AND SUNDRIED TOMATO SEASONING, CONTAINS MILK,  Item # B18122.01,  Net Wt 50 Lb (22.68Kg)
KERRY, HOT BUFFALO WINGS PRETZEL SEAS 173211,  Item # B16413.01,  Net Wt 44.5 Lb (20.18 kg)
KERRY, SOUR CREAM AND ONION 10286,  CONTAINS MILK, Item # I10286.465,  Net Wt 50 Lb (22.68 Kg)
KERRY, PARM GARLIC SEAS 721221,  CONTAINS MILK, Item # 721221.399 & 721221.398 ,  Net Wt 50 Lb (22.68 Kg)
Worldwide Distribution - USA (nationwide) and the countries of:  Nationwide  Foreign: Australia  Austria  Belgium  Bharain  Canada  China  Columbia  Czech Republic  Denmark  Dutch Antilles  Egypt  Estonia  Finland  France  Germany  Hong Kong  Ireland  Israel  Italy  Latvia  Lebanon  Luxembourg  Malaysia  Mexico  Netherlands  New Zealand  Norway  Philippines  Qatar  Russian Fed.  Saudi Arabia  Serbia  Singapore  Slovakia  Slovenia  South Africa  Spain  Sweden  Switzerland  Syria  Taiwan  Thailand  Turkey  United Kingdom
Philips Multi Diagnost Eleva II with swivel cable Product Codes;  708032, 708036  Multi Diagnost Eleva with FlatDetector with swivel cable  Product Codes: 708034, 708037    This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F, performed along with more specialized interventional applications. This includes the following general areas: Digestive system Skeletal system Urinary system Reproductive system Respiratory system Circulatory system Various . Arthrograms . Myelograms . Facet joint injections . Discography SialographyFluoroscopy, Radiography and Angiography
Units with cable swivel delivered from 2007
MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement
Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24.
Lot #: 04510KL*, Exp 01OCT2012; *lot number may have 01 or 02 following it
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer.  The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system.   The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.
Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin.  These products are used by Dental professionals for bonding needs in restorative dental procedures.
USA (nationwide)  AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MO, NV, NH, NC, OH, PA, TX, VA, WA, and WI.
Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A   The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections.
Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.
Worldwide Distribution - US (nationwide) and the country of S. Korea
seprafilm Procedure Pack ADHESION BARRIER Re-order Number: 5086-02      Product Usage:  Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
Sterility of product may be compromised due to packaging defect
seprafilm Single Site ADHESION BARRIER Re-order Number: 6641-01    Product Usage:  Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France    Single offset rasp handle designed to mate to the Accolade femoral broaches to prepare the femoral canal in a total hip anthroplasty using the Accolade Hip System. The offset rasp handle incorporates an offset angle designed to minimize interference with surrounding soft tissue.
510K exempt Catalog Number 1020-1400  Lot Code P5E93
Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.
Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 54868-4229-0
Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole.
Frozen Oysters: 1) CHORIPDONG) FROZEN OYSTER, IQF 8OZ*40; 2) CJ FOOD, INC.)FROZEN OYSTER 8oz*40; Not for Retail Sale, Must be fully cooked before serving.  Distributed by CJ Foods,  Inc., Commerce, CA; 3) JAYONE FOODS, INC.) FROZEN OYSTER 8 oz*40, IQF, Distributed by Jayone Foods, Inc.., Paramount, CA 92723  Product of Korea
1) Item number 3137810; 2) Item number 2237840; 3) Item number 36037800
The product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
OCEAN GREEN)OYSTER LARGE 5lb*6, IQF   Imported by: J & S Group  2535E 12th St. #B  Los Angeles, CA 90021
PACIFIC GIANT) OYSTERS,IQF,KOREA 8 oz*40 Imported by Pacific Giant, Vernon, CA 90058  Product of Korea
popchips Cheddar Potato, Popped Chip Snack, 0.8 oz, UPC  0 82666 78800 3
The firm received ingredient lactic acid from Kerry Ingredients and Flavors that may potentially contain metal fragments.
Cheddar Mini Rice Snacks under the following brand names: Fred Meyer, 3 oz, UPC 0 11110 90004 3;  Kroger, 3 oz, UPC 0 11110 35789 2;  Ralphs, 3 oz, UPC 0 11110 91220 9;  Safeway, 3 oz. UPC 0 21130 29808 2;
Reese Colossal Smoked Oysters.  Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA.  Product of Korea.  UPC 70670-00576
According to information published by the FDA:  Because of inadequate sanitation controls, the molluscan shellfish harvested from Korean waters may have been exposed to human fecal waste and have the potential to be contaminated with a norovirus.
Reese Medium Smoked Oysters.  Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA.  Product of Korea.  UPC 70670-00600.
Reese Petite Smoked Oysters.  Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA.  Product of Korea, UPC 70670-00575.
Smoked Oysters In cottonseed oil sold under the following brand names: 1) Fredmeyer Smoked Oysters In cottonseed oil Net Wt 3.75 oz (106 g) Distributed by Inter-American Products, Cincinnati, Ohio 45202, Product of Korea; 2) Ralph's Smoked Oysters In Cottonseed Oil Distributed by Inter-American Products Cincinnati, Ohio 45202 Product of Korea; 3) Kroger Smoked Oysters In cottonseed oil , Distributed by the Kroger Co., Cincinnati, OH 45202,  Product of Korea
Inspectional evidence and sample analyses as well as reports of food borne illness outbreaks due to norovirus have led FDA to believe that Korean molluscan shellfish and products containing KMS as ingredients are adulterated under Section 40(a)(4) in that they were prepared and held under insanitary conditions, whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health namely from exposure to human fecal waste and contamination with norovirus.
Whole Oysters in Water under the following brand names: 1) Ralph's Whole Oysters in Water, Net Wt. 8 OZ (226 g) Distributed by Inter-American Products, Cincinnati, Ohio 45202, Product of Korea; 2) Kroger Whole Oysters in Water Net Wt. 8 OZ (226g) Distributed by the Kroger Co., Cincinnati, Ohio 45202
Northern Catch Fancy Whole Oysters Net Wt. 8 OZ (227g) Distributed by the Aldi Inc., Batavia, IL 60510   Product of Korea
Product was distributed nationwide and internationally to Australia, Canada, Slovenia, New Zealand, Brunei, Darussalam, Poland and Croatia.
Tempeh Starter Yeast, Rhizopus Oligosporus cultures,  soybean rice flour, Original, packaged in clear plastic packages in 30gm, 50gm, 250 gm, and 1000 gm sizes and labeled in part ***Indonesianfoodmart.com***
123 orders were filled but quantities were not recorded on many invoices
Imported food product tested positive for Salmonella.
Tempeh Super Starter Yeast, Rhizopus Oligosporus cultures, soybean rice flour, packaged in clear plastic packages in 30 gm, 50 gm, 250 gm, and 1000 gm sizes and labeled in part ***Indonesianfoodmart.com***
Oyster Frozen Half Shell; 144 Pc/CS  Processed by:  Dai One Food Co., LTD  #150 Jun-RI, Sanyang-UP  Tongyeong-City  Kyungsangnam-DO.    to:  Khee Trading, Vernon, CA 90058.
Frozen Oyster Meat IQF (Z4) 4 lb box  Packed by Dong Won Mul San Co.  Tongyeong-City, Gyeongsangnam-Do.    Imported by Ayana Group, Inc.  Washington, CA
North Carolina, South Carolina and Tennessee
Granadaisa whole Oysters, Net WT. 8 oz (225 grams); Packed For King Seafoods Inc. PO BOX 107, Mount Holly, NJ USA 08060 Product of Korea Farm Raised, UPC 719882002049.
The US FDA has removed all Korean certified shippers of molluscan shellfish (oysters, clams, mussels and scallops) from the Interstate Shellfish Shippers List (ICSSL), following a comprehensive FDA evaluation that determined that the Korean Shellfish Sanitation Program (KSSP) no longer meets the sanitation controls spelled out under the National Shellfish Sanitation Program.
Red Chambers is recalling Dai One Food Oyster IQF 4lbs, 25 lbs, and 8 oz because the products have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.