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
Physicians Total Care, Inc.
Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 5486...
Oral Drugs·3 affected·Feb 8, 2012
High RiskFDA
Afassco Inc
The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids...
Medical Devices·1,956 affected·Feb 8, 2012
High RiskFDA
Sanofi-aventis Us, Inc.
Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10
Injectable Drugs·196,355 affected·Feb 6, 2012
High RiskFDA
Sanofi-aventis Us, Inc.
Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-059...
Injectable Drugs·387,738 affected·Feb 6, 2012
High RiskFDA
Accumetrics Inc
VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay u...
Diagnostic Devices·26,075 affected·Feb 6, 2012
High RiskFDA
Metrex Research, Llc.
CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled...
Surgical Devices·17,690 affected·Feb 6, 2012
High RiskFDA
Accumetrics Inc
VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or poi...
Diagnostic Devices·1,167 affected·Feb 6, 2012
High RiskFDA
Bottling Llc Dba Pepsi Beverages Company
Diet Crush Orange Soda, 12 oz cans
Beverages·1,791 affected·Feb 5, 2012
High RiskFDA
Hospira Inc.
*** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusi...
Medical Devices·1 affected·Feb 5, 2012
High RiskFDA
Hospira Inc.
Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that...
Medical Devices·12,618 affected·Feb 5, 2012
High RiskFDA
Hospira Inc.
Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that...
Medical Devices·11,973 affected·Feb 5, 2012
High RiskFDA
Hospira Inc.
Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devi...
Medical Devices·12,348 affected·Feb 5, 2012
High RiskFDA
Orthosensor
"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.co...
Medical Devices·9 affected·Feb 4, 2012
High RiskFDA
Lloyd Inc
Thyro-Tab 0.050mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Drugs·1,924,297 affected·Feb 3, 2012
High RiskFDA
Lloyd Inc
Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, NDC 0456-1321-01. Manufactured for Forest Phar...
Oral Drugs·19,166 affected·Feb 3, 2012
High RiskFDA
Abbott Point Of Care Inc.
i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement ...
Cardiac Devices·1,004,200 affected·Feb 1, 2012
High RiskFDA
Abbott Point Of Care Inc.
i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measuremen...
Diagnostic Devices·368,149 affected·Feb 1, 2012
High RiskFDA
Roche Molecular Systems, Inc.
COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the CO...
Medical Devices·2,132 affected·Feb 1, 2012
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Dis...
Medical Devices·532 affected·Jan 26, 2012
High RiskFDA
Exactech, Inc.
REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Ga...
Medical Implants·2 affected·Jan 24, 2012
High RiskFDA
Exactech, Inc.
REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Ga...
Medical Implants·2 affected·Jan 24, 2012
High RiskFDA
Exactech, Inc.
REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Ga...
Medical Implants·2 affected·Jan 24, 2012
High RiskFDA
Ge Healthcare, Llc
VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966;...
Medical Devices·1,296 affected·Jan 23, 2012
High RiskFDA
Atico International Usa, Inc.
Roundy's Rich Fields Butter Cookies. Product is labeled in part: Side of tin: "***RICH FIELDS*** Butter Cookies***NET WT 12 OZ (340g)...
Dairy·22,068 affected·Jan 20, 2012
High RiskFDA
Nihon Kohden America Inc
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifi...
Medical Devices·477 affected·Jan 19, 2012
High RiskFDA
Stryker Spine
Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 htt...
Medical Devices·273 affected·Jan 13, 2012
High RiskFDA
Vital Scientific N.v.
Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
Medical Devices·4 affected·Jan 10, 2012
High RiskFDA
The Anspach Effort, Inc.
"***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Medical Devices·16 affected·Jan 9, 2012
High RiskFDA
Synthes, Inc.
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Medical Implants·38 affected·Jan 6, 2012
High RiskFDA
Cook Ireland Ltd.
Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angi...
Medical Implants·15 affected·Jan 5, 2012
High RiskFDA
Spinefrontier, Inc.
KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between...
Medical Implants·2 affected·Dec 30, 2011
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corpor...
Medical Devices·16,913 affected·Dec 29, 2011
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker Fran...
Medical Devices·41 affected·Dec 29, 2011
High RiskFDA
Us Endoscopy Group Inc
Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampl...
Medical Devices·393 affected·Dec 22, 2011
High RiskFDA
Church & Dwight Inc
Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08...
Medical Devices·1 affected·Dec 22, 2011
High RiskFDA
Church & Dwight Inc
Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Prin...
Medical Devices·0 affected·Dec 22, 2011
High RiskFDA
Church & Dwight Inc
Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton...
Medical Devices·0 affected·Dec 22, 2011
High RiskFDA
Church & Dwight Inc
Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in China. Manufactured for Church and Dwight Co., Inc....
Medical Devices·0 affected·Dec 22, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human ...
Diagnostic Devices·199 affected·Dec 20, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human...
Diagnostic Devices·199 affected·Dec 20, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human a...
Diagnostic Devices·199 affected·Dec 20, 2011
CriticalFDA
Body Basics Inc
Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA
Oral Drugs·30,000 affected·Dec 19, 2011
High RiskFDA
Advanced Neuromodulation Systems Inc.
Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain ...
Medical Devices·25 affected·Dec 19, 2011
High RiskFDA
Advanced Neuromodulation Systems Inc.
The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of...
Medical Devices·30,560 affected·Dec 19, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated slide preparation and stai...
Diagnostic Devices·41 affected·Dec 13, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer is a fully automated slide preparation and ...
Diagnostic Devices·41 affected·Dec 13, 2011
High RiskFDA
Ormco/sybronendo
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
Medical Devices·4,543 affected·Dec 12, 2011
High RiskFDA
Progressive Medical Inc
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamage...
Medical Devices·70 affected·Dec 9, 2011