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
Spinefrontier, Inc.
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserte...
Medical Devices·25 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device...
Medical Devices·3,300 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Bosto...
Medical Devices·425 affected·Nov 20, 2013
High RiskFDA
Spinefrontier, Inc.
Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
Medical Devices·0 affected·Nov 20, 2013
High RiskFDA
Spinefrontier, Inc.
Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
Medical Devices·922 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Distributed by: Bost...
Medical Devices·0 affected·Nov 20, 2013
High RiskFDA
Boston Scientific Corporation
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Distributed by: Boston...
Medical Devices·740 affected·Nov 20, 2013
High RiskFDA
Spinefrontier, Inc.
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter ...
Medical Devices·4 affected·Nov 20, 2013
High RiskFDA
Sorin Group Italia S.r.l.
ORCHESTRA/ORCHESTRA PLUS Programmer
Medical Devices·1,718 affected·Nov 20, 2013
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Dr...
Medical Devices·211 affected·Nov 20, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for ...
Diagnostic Devices·376 affected·Nov 20, 2013
High RiskFDA
Coopervision Inc.
Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK -...
Medical Devices·153 affected·Nov 20, 2013
High RiskFDA
Coopervision Inc.
ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, S...
Medical Devices·45 affected·Nov 20, 2013
High RiskFDA
Nexgen Pharma, Inc.
PCC, Rebecca's Natural Food, Sprouts Famous Market, Ritzman Pharmacy, Earth Fare, Hartig Drug, Viroqua Food, Ramona Fitness Center, Indep...
Supplements·88 affected·Nov 19, 2013
CriticalFDA
Tendex
P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost...
Oral Drugs·0 affected·Nov 19, 2013
CriticalFDA
Tendex
NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boos...
Oral Drugs·0 affected·Nov 19, 2013
CriticalFDA
Vitality Research Labs Llc
vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, Distributed by Vitality Research Labs, LL...
Oral Drugs·11,523 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distribu...
Medical Devices·1,979 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050...
Medical Devices·10,448 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). ...
Medical Devices·352 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100...
Medical Devices·954 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manu...
Medical Devices·246 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manuf...
Medical Devices·834 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors...
Medical Devices·361 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distri...
Medical Devices·454 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-...
Medical Devices·42,699 affected·Nov 19, 2013
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only Devices are used in total kne...
Surgical Devices·625 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P...
Medical Devices·1,944 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-3...
Medical Devices·1,002 affected·Nov 19, 2013
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height Nonsterile Devices are used in total knee arthroplas...
Surgical Devices·684 affected·Nov 19, 2013
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height Nonsterile Devices are used in total knee arthropla...
Surgical Devices·638 affected·Nov 19, 2013
High RiskFDA
Asante Solutions, Inc.
Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distribu...
Medical Devices·1,392 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-3...
Medical Devices·6,684 affected·Nov 19, 2013
High RiskFDA
Zimmer, Inc.
NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non sterile, Rx Only Devices are used in total kne...
Surgical Devices·641 affected·Nov 19, 2013
RecallFDA
Ultradent Products, Inc.
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic tr...
Medical Devices·217 affected·Nov 19, 2013
High RiskFDA
Atrium Medical Corporation
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or flu...
Medical Devices·7,274 affected·Nov 19, 2013
High RiskFDA
Flora Inc
Flora Double Ginger Herbal Tea Blend, 16/1.24 oz (35.2g) tea bags per package. UPC 0 61998 63757 9 The product is labeled in parts: "...
Beverages·6,024 affected·Nov 18, 2013
CriticalFDA
Baxter Healthcare Corp.
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1...
Injectable Drugs·49,932 affected·Nov 18, 2013
CriticalFDA
Ss Wholesale Inc. Dba Jobbers Wholesale
eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6.
Oral Drugs·2,395 affected·Nov 18, 2013
CriticalFDA
Baxter Healthcare Corp.
Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter ...
Injectable Drugs·7,388 affected·Nov 18, 2013
RecallFDA
Fougera Pharmaceuticals Inc.
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, ND...
Topical Drugs·31,122 affected·Nov 18, 2013
CriticalFDA
Fossil Fuel Products, Llc
RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309
Oral Drugs·50,300 affected·Nov 18, 2013
CriticalFDA
Baxter Healthcare Corp.
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber...
Injectable Drugs·7,068 affected·Nov 18, 2013
CriticalFDA
Ss Wholesale Inc. Dba Jobbers Wholesale
MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.
Oral Drugs·2,395 affected·Nov 18, 2013
CriticalFDA
Baxter Healthcare Corp.
Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Bax...
Injectable Drugs·14,574 affected·Nov 18, 2013
CriticalFDA
Ss Wholesale Inc. Dba Jobbers Wholesale
Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA 90621, English U...
Oral Drugs·2,395 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibi...
Medical Devices·29,235 affected·Nov 18, 2013
High RiskFDA
Depuy Orthopaedics, Inc.
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibi...
Medical Devices·29,235 affected·Nov 18, 2013