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
Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10" (25 CM) LONG. The Sarns High Flow Aortic Arch ...
Medical Devices·133,793 affected·May 9, 2012
CriticalFDA
Natus Medical Incorporated
The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-i...
Medical Devices·324 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG, WITH XCOATING SURFACE COATING. The Sarns...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the a...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placeme...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LO...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement ...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for place...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Covidien Lp
Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, g...
Medical Devices·13,531 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch...
Medical Devices·133,793 affected·May 9, 2012
High RiskFDA
Terumo Cardiovascular Systems Corporation
X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement...
Cardiac Devices·53,139 affected·May 9, 2012
High RiskFDA
Covidien Lp
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gy...
Medical Devices·50,698 affected·May 9, 2012
High RiskFDA
Raysearch Laboratories Ab
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Produ...
Medical Devices·19 affected·May 9, 2012
High RiskFDA
Mexicantown Wholesale
MAGDALENA QTY: 54 MEXICANTOWN BAKERY 313-894-2000
Food·108 affected·May 8, 2012
High RiskFDA
Mexicantown Wholesale
CONCHA CHOCOLATE QTY: 90 MEXICANTOWN BAKERY 313-894-2000
Snacks & Candy·180 affected·May 8, 2012
High RiskFDA
Mexicantown Wholesale
CUERNOS (CROISSANT) QTY: 90 MEXICANTOWN BAKERY 313-894-2000
Food·90 affected·May 8, 2012
High RiskFDA
Seoul Shik Poom, Inc.
Frozen Salted Clam, 12/210g. Distributed by: Seoul Shik Poom, Engleside, NJ. Origin: Republic of Korea.
Frozen Food·3 affected·May 8, 2012
High RiskFDA
Mexicantown Wholesale
TORTUGAS QTY: 60 MEXICANTOWN BAKERY 313-894-2000
Food·120 affected·May 8, 2012
High RiskFDA
Mexicantown Wholesale
TACOS DE MANZANA QTY: 120 MEXICANTOWN BAKERY 313-894-2000
Food·120 affected·May 8, 2012
High RiskFDA
Seoul Shik Poom, Inc.
Frozen Oysters, Net Wt 1 LBS (454g). Distributed by: Seoul Shik Poom, Engleside, NJ. Origin: Republic of Korea.
Seafood·412 affected·May 8, 2012
High RiskFDA
Mexicantown Wholesale
CONCHA BLANCAS (VANILLA) QTY: 90 MEXICANTOWN BAKERY 313-894-2000
Food·180 affected·May 8, 2012
High RiskFDA
Panera Bread Llc
Panera ,HAZELNUT CREAM CHEESE SPREAD Reduced Fat, 8 0z , Refrigerated
Dairy·110,718 affected·May 8, 2012
High RiskFDA
Panera Bread Llc
Panera HONEY WALNUT CREAM CHEESE SPREAD, Reduced Fat, 8 0z Refrigerated
Dairy·198,646 affected·May 8, 2012
High RiskFDA
Mexicantown Wholesale
EMPANADA PINA QTY: 100 MEXICANTOWN BAKERY 313-894-2000
Food·100 affected·May 8, 2012
High RiskFDA
Mexicantown Wholesale
POLVORONES AMARILLO QTY: 100 MEXICANTOWN BAKERY 313-894-2000
Food·200 affected·May 8, 2012
High RiskFDA
Mexicantown Wholesale
TACOS DE PINA QTY: 120 MEXICANTOWN BAKERY 313-894-2000
Food·120 affected·May 8, 2012
Medium RiskFDA
Morton Salt Co.
Morton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber drums, and semi-bulk bags. Product is shipped in 80 lb bags,...
Drugs·531,950 affected·May 8, 2012
High RiskFDA
Bayer Healthcare Pharmaceuticals Inc.
Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13...
Drugs·112 affected·May 8, 2012
Medium RiskFDA
Hill Dermaceuticals, Inc.
Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Ma...
Topical Drugs·161,064 affected·May 8, 2012
Medium RiskFDA
Hill Dermaceuticals, Inc.
Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distrib...
Topical Drugs·111,816 affected·May 8, 2012
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista Syste...
Diagnostic Devices·59,735 affected·May 8, 2012
High RiskFDA
Sunny Seafoods Inc
Half Shell Oyster Imported By: KORYEO INT'L CORP 200 STEWART AVENUE, BROOKLYN, NY 11237; SPEC 72PCS; COUNTRY OF ORIGIN: REPUBLIC OF KORE...
Seafood·150,000 affected·May 7, 2012
High RiskFDA
Sunny Seafoods Inc
AquaRoyale Oyster IQF Packed By Dai One Food.Co., LTD. Packed For: Sunny Seafoods, Inc. 11 Sunflower Avenue, Paramus, NJ 07652. USA NET W...
Seafood·80,000 affected·May 7, 2012
High RiskFDA
Sunny Seafoods Inc
Frozen Cooked Oyster: 1) Cooked Oyster 40-90 CT/LB IQF Packed By: Dai One Food.Co., LTD. Country of Origin: Republic of Korea. NET WT.: 4...
Seafood·1 affected·May 7, 2012
RecallFDA
Guthy-renker Llc
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, MEDIUM, 7 g/0.25 OZ. Compacts, Over the...
Injectable Drugs·5,025 affected·May 7, 2012
RecallFDA
Endo Pharmaceuticals, Inc.
Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceu...
Oral Drugs·11,764 affected·May 7, 2012
RecallFDA
Guthy-renker Llc
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, DARK, 7 g/0.25 OZ. Compacts, Over the C...
Injectable Drugs·2,537 affected·May 7, 2012
RecallFDA
Guthy-renker Llc
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, LIGHT, 7 g/0.25 OZ. Compacts, Over the ...
Injectable Drugs·29,341 affected·May 7, 2012
RecallFDA
Guthy-renker Llc
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, FAIR, 7 g/0.25 OZ. Compacts, Over the C...
Injectable Drugs·9,960 affected·May 7, 2012
RecallFDA
Guthy-renker Llc
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, TAN, 7 g/0.25 OZ. Compacts, Over the Co...
Injectable Drugs·4,526 affected·May 7, 2012
High RiskFDA
Jk Products & Services, Inc
BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
Medical Devices·598 affected·May 7, 2012
High RiskFDA
Civco Medical Instruments Inc
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRA...
Medical Devices·24 affected·May 7, 2012
High RiskFDA
Civco Medical Instruments Inc
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, ...
Medical Devices·30 affected·May 7, 2012
High RiskFDA
Non-invasive Monitoring Systems, Inc.
USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautio...
Medical Devices·2 affected·May 7, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer re...
Medical Devices·241 affected·May 7, 2012
High RiskFDA
Mti Precision Products Llc.
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
Medical Devices·134 affected·May 7, 2012
High RiskFDA
Mindray Ds Usa, Inc. D.b.a. Mindray North America
V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the dire...
Cardiac Devices·979 affected·May 7, 2012
High RiskFDA
Interactive Motion Technologies, Inc.
Robotic hand accessory to InMotion Arm, rehabilitation robot.
Medical Devices·8 affected·May 5, 2012