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
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, ...
Medical Devices·29,815,600 affected·Dec 3, 2015
CriticalFDA
Jem Raw Chocolate, Llc
Superberry Maqui Camu - Sprouted Almond Spread. Product is packaged in glass jars, sold under brand name JEM Raw Organics. Net wt. 1...
Produce·0 affected·Dec 2, 2015
CriticalFDA
Bay Valley Foods
Crispers Honey Lime Dressing, 1 GL, Distributed by Bay Valley Foods, LLC, Oak Brook, IL 60523
Food·36 affected·Dec 2, 2015
RecallFDA
Gutierrez Distributors, Llc
Gutierrez Distributor, (a) Tarugo con chile spicy tamarind, 349 Chestnut Street, Passaic, NJ 07055 UPC 8527050000904 (b) Dulce de pulp...
Food·240 affected·Dec 2, 2015
CriticalFDA
Jem Raw Chocolate, Llc
Cinnamon Red Maca - Sprouted Almond Spread. Product is packaged in glass jars, sold under brand name JEM Raw Organics. Net wt. 1 oz....
Food·0 affected·Dec 2, 2015
CriticalFDA
Jem Raw Chocolate, Llc
Cashew Cardamom - Sprouted Cashew Almond Spread. Product is packaged in glass jars, sold under brand name JEM Raw Organics. Net wt. ...
Food·0 affected·Dec 2, 2015
CriticalFDA
Jem Raw Chocolate, Llc
Coconut Cardamom - Sprouted Almond Spread. Product is packaged in glass jars, sold under brand name JEM Raw Organics. Net wt. 1 oz., ...
Food·0 affected·Dec 2, 2015
CriticalFDA
Jem Raw Chocolate, Llc
Hazelnut Raw Cacao - Sprouted Hazelnut Spread. Product is packaged in glass jars, sold under brand name JEM Raw Organics. Net wt. 1 ...
Food·0 affected·Dec 2, 2015
RecallFDA
Pfizer Inc.
Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500...
Oral Drugs·4,005 affected·Dec 2, 2015
CriticalFDA
Medtronic
Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product Usage: The Endo GIA Ultra U...
Medical Devices·2,711 affected·Dec 2, 2015
High RiskFDA
Zimmer Manufacturing B.v.
Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3;...
Medical Devices·179 affected·Dec 2, 2015
High RiskFDA
Biomet, Inc.
Black Mamba Suture Passer
Medical Devices·50 affected·Dec 2, 2015
High RiskFDA
Biomet, Inc.
Green Mamba Suture Passer
Medical Devices·13 affected·Dec 2, 2015
CriticalFDA
Medtronic
Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal Short, End...
Medical Devices·364,768 affected·Dec 2, 2015
High RiskFDA
Reser's Fine Foods Inc.
Winn Dixie Old Fashioned Potato Salad, Net Wt. 16oz (1 LB) 454g.
Produce·144 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quan...
Diagnostic Devices·834 affected·Dec 1, 2015
High RiskFDA
3m Company - Health Care Business
3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
Medical Devices·167 affected·Dec 1, 2015
High RiskFDA
Microbiologics Inc
QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) ...
Medical Devices·8 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining a...
Medical Devices·751 affected·Dec 1, 2015
High RiskFDA
Josnoe Medical, Inc.
PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
Medical Devices·1,008 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobia...
Medical Devices·2,706 affected·Dec 1, 2015
High RiskFDA
Synthes (usa) Products Llc
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
Surgical Devices·65 affected·Dec 1, 2015
CriticalFDA
Draeger Medical, Inc.
Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit inten...
Respiratory Devices·2,422 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automat...
Medical Devices·666 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobia...
Medical Devices·284 affected·Dec 1, 2015
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining a...
Medical Devices·715 affected·Dec 1, 2015
High RiskFDA
Microbiologics Inc
QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb)...
Medical Devices·541 affected·Dec 1, 2015
High RiskFDA
Aesculap, Inc.
Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicat...
Medical Devices·1,232 affected·Nov 30, 2015
High RiskFDA
Bayer Healthcare
Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine dia...
Diagnostic Devices·198,598 affected·Nov 30, 2015
High RiskFDA
Acumedia Manufacturers, Inc.
Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the ...
Medical Devices·28 affected·Nov 30, 2015
High RiskFDA
Verathon, Inc.
GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope ...
Medical Devices·448 affected·Nov 30, 2015
High RiskFDA
Verathon, Inc.
BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 027...
Medical Devices·2,524 affected·Nov 30, 2015
High RiskFDA
Baxter Healthcare Corp.
Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product Usage: C8581: ...
Medical Devices·9,600 affected·Nov 30, 2015
High RiskFDA
Baxter Healthcare Corp.
Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory t...
Medical Devices·77,136 affected·Nov 30, 2015
High RiskFDA
Aga Gas Inc
Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01
Drugs·1,500 affected·Nov 29, 2015
High RiskFDA
Leica Microsystems, Inc.
Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intend...
Diagnostic Devices·3,745 affected·Nov 27, 2015
RecallFDA
B & D Seafoods Inc
Pacific Surf Swai Fillets IQF 2 lbs x 5/ctn, 5 lbs x 6/ctn (size 7-9) Farm Raised Product of Vietnam Packed for: PAFCO Global Seafoo...
Meat & Poultry·2,113 affected·Nov 25, 2015
RecallFDA
B & D Seafoods Inc
B&D Seafoods Basa Choice Swai Fillets IQF 15 lbs x 1/case (size 5-7, 7-9, 9-11), 11 lbs 2/case (size 6-8) Farm Raised Distributed b...
Meat & Poultry·7,072 affected·Nov 25, 2015
RecallFDA
B & D Seafoods Inc
Happy Fish Swai Fillet Farm Raised Product of Vietnam Net Weight: 22 lbs IQF well trimmed, boneless, skinless, belly off, fat off...
Meat & Poultry·1,818 affected·Nov 25, 2015
RecallFDA
Golden State Medical Supply Inc.
MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx ...
Oral Drugs·737 affected·Nov 25, 2015
RecallFDA
Golden State Medical Supply Inc.
MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spr...
Oral Drugs·1,136 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Provide Protection Cap Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Conical 25 degree Angled Abutment Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Medical Devices·5,569 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Conical 17 degree Angled Abutment Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Biomet 3i, Llc
Certain Bellatek Encode Healing Abutment Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015