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
Ge Healthcare, Llc
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monito...
Medical Devices·1,794 affected·Apr 9, 2014
CriticalFDA
Buffalo Sav, Inc.
GRANDMA'S perogies POTATO & BACON PEROGIES, NET WEIGHT 907 g (32 oz/2 lb), UPC 8 92691 00112 7. Product packed in plastic bag with pink ...
Food·128 affected·Apr 8, 2014
High RiskFDA
Pfizer Inc.
Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-58...
Oral Drugs·23,064 affected·Apr 8, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the f...
Medical Devices·4,462 affected·Apr 8, 2014
High RiskFDA
Synthes, Inc.
Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For...
Medical Devices·3 affected·Apr 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in d...
Medical Devices·664 affected·Apr 8, 2014
High RiskFDA
Bio-rad Laboratories, Inc.
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vit...
Diagnostic Devices·457 affected·Apr 8, 2014
High RiskFDA
Philips Medical Systems, Inc.
Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, ...
Diagnostic Devices·247 affected·Apr 8, 2014
CriticalFDA
Sinco Inc.
Archer Farms Brand Chocolate Hazelnut Swirl Gelato (Italian Ice Cream), 30 FL OZ. plastic tub, frozen. Product of Italy UPC 085239-703618
Dairy·7,044 affected·Apr 7, 2014
CriticalFDA
Natural Grocers By Vitamin Cottage
Natural Grocers by Vitamin Cottage, Pepper Black Whole Organic, about 0.30 lb, UPC 201046804762, packaged in plastic bags.
Supplements·7,327 affected·Apr 7, 2014
High RiskFDA
Piramal Critical Care, Inc.
Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden Circle, Bet...
Drugs·12,600 affected·Apr 7, 2014
High RiskFDA
Teva Pharmaceuticals Usa
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 00...
Oral Drugs·53,452 affected·Apr 7, 2014
High RiskFDA
Teva Pharmaceuticals Usa
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 00...
Oral Drugs·17,181 affected·Apr 7, 2014
High RiskFDA
Small Bone Innovations, Inc.
SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticul...
Medical Devices·44 affected·Apr 7, 2014
High RiskFDA
Western / Scott Fetzer Company
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
Medical Devices·118,325 affected·Apr 7, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]....
Cardiac Devices·101 affected·Apr 7, 2014
High RiskFDA
Jas Diagnostics Inc.
Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
Diabetes Devices·407 affected·Apr 7, 2014
CriticalFDA
H Group
TRADER GIOTTO'S CAESAR SALAD with Caesar Dressing, NET WT. 8/5 OZ (241g).
Produce·509 affected·Apr 5, 2014
CriticalFDA
Frontier Natural Products Co-op
1) Frontier Natural Products Co-op, Whole Black Peppercorns, Certified Organic, Piper nigrum. Net 11.3 Kg 25 LB. Packaged in corrugated c...
Food·91,357 affected·Apr 4, 2014
RecallFDA
Carmel Food Group, Inc.
RISING MOON ORGANICS BASIL ASIAGO PINE NUT PESTO RAVIOLI; 8 OZ PACKAGE (227g) Keep Frozen USDA Organic: Distributed by Rising Moon...
Frozen Food·900 affected·Apr 4, 2014
CriticalFDA
Lisy Corp.
Lisy Sweet Basil Albahaca Net WT/Cont. Neto 6oz. (171g) Item 1132 www.lisycorp.com Packed on a clear plastic container with a UPC # 0 96...
Food·133 affected·Apr 4, 2014
High RiskFDA
Whole Foods Market
The Kitchen Whole Foods Chipotle Chicken Wrap; Good to Go. Net Weight: 10 oz.. (283 g) individually wrapped sandwich wraps. Distrib...
Meat & Poultry·229 affected·Apr 4, 2014
RecallFDA
Boehringer Ingelheim Roxane Inc
Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
Oral Drugs·8,304 affected·Apr 4, 2014
RecallFDA
Boehringer Ingelheim Roxane Inc
Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11
Oral Drugs·98,560 affected·Apr 4, 2014
High RiskFDA
Medtronic Neuromodulation
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usa...
Medical Implants·13,784 affected·Apr 4, 2014
High RiskFDA
Smith & Nephew Inc
TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203,...
Medical Devices·1,253 affected·Apr 4, 2014
High RiskFDA
Smith & Nephew Inc
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, ...
Medical Devices·1,253 affected·Apr 4, 2014
High RiskFDA
Steris Corporation
Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. ...
Surgical Devices·68 affected·Apr 4, 2014
High RiskFDA
Philips Medical Systems, Inc.
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, an...
Medical Devices·188,520 affected·Apr 4, 2014
High RiskFDA
Bd Biosciences, Systems & Reagents
Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified a...
Diagnostic Devices·12 affected·Apr 4, 2014
RecallFDA
Bread Stop Bakery, Llc
the BREAD STOP Amaranth 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
Bakery & Grains·100 affected·Apr 3, 2014
RecallFDA
Bread Stop Bakery, Llc
the BREAD STOP Flaxseed Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
Bakery & Grains·80 affected·Apr 3, 2014
RecallFDA
Bread Stop Bakery, Llc
the BREAD STOP Oatmeal Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
Bakery & Grains·150 affected·Apr 3, 2014
RecallFDA
Bread Stop Bakery, Llc
the BREAD STOP Sourdough Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
Bakery & Grains·200 affected·Apr 3, 2014
RecallFDA
Bread Stop Bakery, Llc
the BREAD STOP Country White Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
Bakery & Grains·150 affected·Apr 3, 2014
RecallFDA
Bread Stop Bakery, Llc
the BREAD STOP Spelt and Millet Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
Bakery & Grains·50 affected·Apr 3, 2014
RecallFDA
Bread Stop Bakery, Llc
the BREAD STOP Honey Wheat Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
Bakery & Grains·500 affected·Apr 3, 2014
RecallFDA
Bread Stop Bakery, Llc
the BREAD STOP Wheat Sourdough 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
Bakery & Grains·200 affected·Apr 3, 2014
High RiskFDA
Ge Healthcare
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare...
Diagnostic Devices·297 affected·Apr 3, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, arc...
Medical Devices·50 affected·Apr 3, 2014
High RiskFDA
B. Braun Medical, Inc.
Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia
Medical Devices·7,400 affected·Apr 3, 2014
High RiskFDA
Shimadzu Medical Systems
Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital w...
Medical Devices·685 affected·Apr 3, 2014
High RiskFDA
Boston Scientific Corporation
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.
Medical Devices·9 affected·Apr 3, 2014
High RiskFDA
Koru Pacific Packaging, Inc.
Ah! Laska Organic Cocoa Non Dairy Chocolate Mix; Low Fat, Vegan, USDA Organic; Net Wt. 12 oz. (340 g); UPC 7-60519-10028-7; Ingred...
Dairy·2,708 affected·Apr 2, 2014
High RiskFDA
Fong Kee Tofu Co., Inc.
Soy Bean Cake Net Wt. 9. oz. Ingredient: Soybeans, water, salt, Soy sauce, Spice, Calcium Sulfate. Perishable, keep refrigerated. Fon...
Bakery & Grains·45 affected·Apr 2, 2014
CriticalFDA
Hospira Inc.
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira...
Injectable Drugs·844,300 affected·Apr 2, 2014
High RiskFDA
Ge Healthcare
Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based ...
Respiratory Devices·723 affected·Apr 2, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic extern...
Cardiac Devices·9,872 affected·Apr 2, 2014