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
Atricure Inc
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablat...
Cardiac Devices·19,190 affected·Nov 21, 2014
High RiskFDA
Becton Dickinson & Co.
BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.
Medical Devices·92,710 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Bronchial One Lumen Tube - Left
Medical Devices·0 affected·Nov 21, 2014
High RiskFDA
Smiths Medical Asd, Inc.
Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Nee...
Medical Devices·47,200 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Bronchial Double Lumen Tube Set (Left), Sterile
Medical Devices·6,991 affected·Nov 21, 2014
High RiskFDA
Smiths Medical Asd, Inc.
Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Need...
Medical Devices·334,000 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Bronchial One Lumen Tube - Right
Medical Devices·0 affected·Nov 21, 2014
High RiskFDA
Zimmer Manufacturing B.v.
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-...
Medical Devices·6,377 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Tracheopart Set (Right), Sterile
Medical Devices·0 affected·Nov 21, 2014
High RiskFDA
Flying Cow Creamery
whole milk yogurt is packaged in a 32 oz. glass jar, sold under brand Flying Cow Creamery. The UPC is 7 13757 87133 4. The product is...
Dairy·117 affected·Nov 20, 2014
CriticalFDA
Evershing International Trading Inc.
Wake-Up Instant Coffee Mix (weasel coffee) Melange de Cafe Instantane Ca Phe Hoa Tan (huong caon) 3 in one; sold in two packing confi...
Dairy·5,949 affected·Nov 20, 2014
CriticalFDA
Acme Smoked Fish Corp.
SMOKED NOVA Salmon, NET WT 4 oz (113g). Product is held in vacuum packs with black, beige and yellow labeling. Distributred by ACME Smo...
Seafood·188 affected·Nov 20, 2014
High RiskFDA
One And Zen
GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY
Oral Drugs·38 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfac...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the ...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Philips Medical Systems, Inc.
Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeab...
Medical Devices·79 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfac...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the body below t...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the ...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfa...
Surgical Devices·13,041 affected·Nov 20, 2014
High RiskFDA
Ricos Tostaditos, Inc.
RICOS Tostaditos Vegetal Skins Imitation Rinds Chicharron Vegetal Hot Crispy and Delicious Net Wt. 3/4 oz. (21g)
Food·150 affected·Nov 19, 2014
High RiskFDA
Ricos Tostaditos, Inc.
RICOS Tostaditos Vegetal Skins Imitation Rinds Chicharron Vegetal Crispy and Delicious Net Wt. 3/4 oz. (21g)
Food·300 affected·Nov 19, 2014
High RiskFDA
Ricos Tostaditos, Inc.
RICOS Tostaditos Chiviricos Fried Dough Crispy and Delicious Net Wt. 2-1/4 oz. (64g)
Food·4,000 affected·Nov 19, 2014
High RiskFDA
American Health Packaging
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories I...
Oral Drugs·3,496 affected·Nov 19, 2014
High RiskFDA
Brainlab Ag
iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radi...
Medical Devices·1,412 affected·Nov 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Prod...
Cardiac Devices·74,499 affected·Nov 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for...
Cardiac Devices·27,918 affected·Nov 19, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitativ...
Diagnostic Devices·658 affected·Nov 19, 2014
High RiskFDA
Natus Medical Incorporated
Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.
Medical Devices·1,907 affected·Nov 19, 2014
High RiskFDA
Kci Usa, Inc.
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H2...
Medical Devices·1,139 affected·Nov 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Cardiac Devices·1,553 affected·Nov 19, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator sy...
Medical Devices·3 affected·Nov 19, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics. The VIT...
Diagnostic Devices·339 affected·Nov 19, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for the measurement of the transcutaneo...
Medical Devices·86 affected·Nov 19, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-...
Diagnostic Devices·1,830 affected·Nov 19, 2014
RecallFDA
Tastefully Simple, Inc
Product comes in as part of Fabulous Fudge Gift Box. The Gift box contains 2 samples of the recalled product, Cookies & Cream Fudge and 2...
Dairy·4,257 affected·Nov 18, 2014
High RiskFDA
Cheesecake Royale, Inc.
Lemoncello Mascarpone Cake, 14 Slices, KEEP FROZEN, NET Wt. 6.25 lbs (2.8kg), UPC#85538300088, Manufactured by: Cheesecake Royale, Inc. D...
Dairy·70 affected·Nov 17, 2014
High RiskFDA
Cheesecake Royale, Inc.
Turtle Fudge Brownies, Net Wt. (5 lbs), Item # 042, UPC#85538300042
Food·31 affected·Nov 17, 2014
CriticalFDA
Karlsburger Foods, Inc.
Karlsburger Foods Low Sodium Taco Seasoning, Item Numbers 16423 (Packaged in 23 oz resealable plastic containers), Item #16465 (Packaged ...
Food·1,491 affected·Nov 17, 2014
CriticalFDA
Karlsburger Foods, Inc.
Karlsburger Foods Taco Seasoning, Item Numbers 43823 (Packaged in 23 oz resealable plastic containers), Item #43807 (Packaged in 7 lb. re...
Food·1,122 affected·Nov 17, 2014
High RiskFDA
Cheesecake Royale, Inc.
Rocky Road Brownies, Net Wt. (5 lbs), Item # 041, UPC#85538300041
Food·256 affected·Nov 17, 2014
RecallFDA
Nutri-dyn Midwest, Inc.
Nutri-Dyn, 5-HTP Extra Strength, Pharmaceutical Grade from Switzerland, Dietary Supplement 60 capsules in plastic bottle, 5-Hydroxytrypto...
Supplements·1,627 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and ...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and ...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, ALLIGATOR FORCEPS, P/N 0250080316. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of ...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 Laparoscopic Manual Instruments are intended for cutting, holding, grasping...
Surgical Devices·180,573 affected·Nov 17, 2014
High RiskFDA
Stryker Endoscopy
PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and ma...
Surgical Devices·180,573 affected·Nov 17, 2014