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
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68,659 recalls
High RiskFDA
North Fish Usa
Cold smoked Mackerel, vacuum packaged, one fish per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
Seafood·1,447 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Sliced cold smoked Escolar, 8 oz and 1 lb, vacuum packaged. Manufactured by North Fish USA, Pembroke Pines, FL 33009
Seafood·8 affected·Mar 16, 2016
High RiskFDA
Bumble Bee Foods Llc
Bumble Bee Chunk Light Tuna in Water, 6cans, 4pk, 5oz, UPC 8660000736
Seafood·20,721 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Cold smoked white fish, vacuum packaged, one fish per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
Seafood·167 affected·Mar 16, 2016
CriticalFDA
Way Fong Llc
FRIED SHRIMP FLAVOURED FISH BAR, Net Wt 9.07 Kg 4 X 5 lbs. bulk, Product of Canada, KEEP REFRIGERATED
Seafood·15 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Salted Mackerel, vacuum packaged, one fish per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
Seafood·160 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Cold smoked Saira (Saury), vacuum packaged, 3 pieces per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
Seafood·186 affected·Mar 16, 2016
High RiskFDA
Tarry Medical Products, Inc.
DandleLION Kisses, 24% Sterile Organic Sucrose In Purified Water, 2 ml polyethylene vial. For oral use Part Number D 12442 C384
Beverages·86 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Cold smoked Sliced Fish Assorted (cold smoked Salmon and Escolar), 8 oz and 1 lb, vacuum packaged. Manufactured by North Fish USA, Pembr...
Seafood·8 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Cold smoked sliced Salmon 8 oz and 1 lb, vacuum packaged. Manufactured by North Fish USA, Pembroke Pines, FL 33009
Seafood·8 affected·Mar 16, 2016
Medium RiskFDA
Actavis Pharma Inc
Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophtha...
Topical Drugs·447,150 affected·Mar 16, 2016
High RiskFDA
Terumo Medical Corporation
PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque ...
Medical Devices·1,370,995 affected·Mar 16, 2016
High RiskFDA
Optovue, Inc.
iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic:...
Medical Devices·40 affected·Mar 16, 2016
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control S...
Cardiac Devices·248 affected·Mar 16, 2016
High RiskFDA
Nuwati Herbals Inc
Nuwati Herbals SeeLessO'Me Diet and Weight Management Tea packaged in two different size amber glass jars with Net Wt 3 oz. or Net Wt 6 o...
Beverages·2,600 affected·Mar 15, 2016
Medium RiskFDA
Hospira Inc.
Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx...
Injectable Drugs·103,600 affected·Mar 15, 2016
CriticalFDA
Invacare Corporation
Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intende...
Medical Devices·3,050 affected·Mar 15, 2016
High RiskFDA
Merit Medical Systems, Inc.
Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when pa...
Cardiac Devices·25 affected·Mar 15, 2016
CriticalFDA
Invacare Corporation
Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to...
Medical Devices·2,702 affected·Mar 15, 2016
CriticalFDA
Invacare Corporation
Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to pro...
Medical Devices·2,184 affected·Mar 15, 2016
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patien...
Respiratory Devices·952 affected·Mar 15, 2016
High RiskFDA
Polymer Technology Systems, Inc.
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Medical Devices·6,467 affected·Mar 15, 2016
High RiskFDA
Ventlab Llc
STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical s...
Respiratory Devices·2,430 affected·Mar 15, 2016
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare System X-ray Tomography Computed :
Medical Devices·1,363 affected·Mar 15, 2016
CriticalFDA
Mevion Medical Systems, Inc.
MEVION S250 for Proton Radiation Therapy
Medical Devices·5 affected·Mar 15, 2016
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment mo...
Medical Devices·0 affected·Mar 15, 2016
High RiskFDA
Roche Molecular Systems, Inc.
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
Medical Devices·8 affected·Mar 15, 2016
High RiskFDA
King Soopers Bakery
Bakery Fresh Goodness Apple Strudel 5 count, 24oz, packaged in Plastic container, distributed by King Soopers Bakery, Denver, CO.
Food·411 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Injectable Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Pol...
Injectable Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories,...
Injectable Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Impax Laboratories, Inc.
Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ ...
Oral Drugs·67,428 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, In...
Injectable Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Impax Laboratories, Inc.
Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 0...
Oral Drugs·18,936 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories,...
Injectable Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc...
Injectable Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Meditech Laboratories, Inc
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave...
Drugs·1,320 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UP...
Surgical Devices·2,716 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. The Va...
Medical Devices·328 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , Rx ONLY The Xcela PICC with PASV, Xcela Hybrid ...
Medical Devices·2 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PA...
Surgical Devices·150 affected·Mar 14, 2016
High RiskFDA
Ossur H / F
Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders ...
Medical Devices·435 affected·Mar 14, 2016
High RiskFDA
Ossur H / F
Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders ...
Medical Devices·435 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid...
Surgical Devices·60 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's...
Medical Devices·5,566 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M00...
Medical Devices·1,127 affected·Mar 14, 2016
High RiskFDA
Navilyst Medical, Inc., An Angiodyamics Company
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONLY The Xcela PICC with PASV, Xcela H...
Medical Devices·190 affected·Mar 14, 2016
High RiskFDA
Ossur H / F
Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorder...
Medical Devices·435 affected·Mar 14, 2016