Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
www.fda.gov →Official Site

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68,659 recalls
High RiskFDA
American Beverage Corp
Guzzler Citrus Punch, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
Beverages·250,000 affected·May 15, 2012
High RiskFDA
American Beverage Corp
Guzzler Alpine Freeze, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
Beverages·250,000 affected·May 15, 2012
High RiskFDA
American Beverage Corp
Guzzler Kiwi-Strawberry, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
Beverages·250,000 affected·May 15, 2012
High RiskFDA
American Beverage Corp
Big Hug Fruit Barrel Grape in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Beverages·250,000 affected·May 15, 2012
High RiskFDA
American Beverage Corp
Big Burst Blue Raspberry Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Beverages·250,000 affected·May 15, 2012
High RiskFDA
American Beverage Corp
Big Hug Fruit Barrel Kiwi Strawberry, in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Beverages·250,000 affected·May 15, 2012
High RiskFDA
American Beverage Corp
Big Burst Fruit Punch Drink, in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
Beverages·250,000 affected·May 15, 2012
High RiskFDA
American Beverage Corp
Guzzler Orchard Chill, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
Beverages·250,000 affected·May 15, 2012
High RiskFDA
Polymer Technology Systems, Inc.
PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine mea...
Medical Devices·1,650 affected·May 15, 2012
High RiskFDA
Abbott Laboratories
Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott La...
Injectable Drugs·121,000 affected·May 14, 2012
High RiskFDA
Alere San Diego, Inc.
Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used w...
Diagnostic Devices·9,997 affected·May 14, 2012
High RiskFDA
Hartmann Usa, Inc
Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debr...
Medical Devices·101,546,391 affected·May 14, 2012
CriticalFDA
Hospira Inc.
HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per ...
Injectable Drugs·223,750 affected·May 12, 2012
High RiskFDA
Invuity, Inc.
BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. T...
Surgical Devices·197 affected·May 12, 2012
High RiskFDA
Young Ocean, Inc
Salted/marinated Pollock roe packaged in white plastic trays with either a clear or opaque plastic lid. Product is packaged in 1.0 lb., 2...
Food·1,920 affected·May 11, 2012
High RiskFDA
Brinkhoff & Monoson Inc
Organic Paprika packaged under the following labels: (1) Archer Farms organic Paprika, packaged in 1.0-oz rectangle glass bottles, pac...
Food·3,132 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the kit are used to maintain the patency of indwel...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled ...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwell...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain th...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled s...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain th...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled ...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included in the kit are used to maintain the pa...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwell...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box Prefilled syringes are...
Surgical Devices·0 affected·May 11, 2012
High RiskFDA
Spacelabs Healthcare, Llc
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0...
Medical Devices·114 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring.
Surgical Devices·32,145 affected·May 11, 2012
High RiskFDA
Persimmon Hill Farm Gourmet Foods
Persimmon Hill Farm, Shiitake Mushroom Sauce, packaged in 8 oz/glass jars. The firm name on the label is Persimmon Hill Farm, 367 Persimm...
Food·120 affected·May 10, 2012
High RiskFDA
Wanchese Fish Company
Oysters, IQF Standard, packed in 5 lb polyethlene bags, further packaged as 2 bags/box and 6 bags/box, and labeled in part ***Wanchese Fi...
Seafood·0 affected·May 9, 2012
High RiskFDA
Wanchese Fish Company
Oysters, Breaded IQF, 20-25 count, packed in 2 lb polyethylene bags, 5 bags/carton, and labeled in part ***Wanchese Fish Company, 2000 No...
Seafood·0 affected·May 9, 2012
High RiskFDA
Wanchese Fish Company
Oysters, IQF Select, packed in 5 lb polyethlene bags, further packaged as 2 bags/box and 6 bags/box, and labeled in part ***Wanchese Fish...
Seafood·0 affected·May 9, 2012
High RiskFDA
Grandpa Brands Co
Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY
Drugs·2,501 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6" (15 CM) LONG Produ...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
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...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
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...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
FX PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root ...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
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 Ca...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LON...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta duri...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
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 ...
Medical Devices·133,793 affected·May 9, 2012