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
www.fda.gov →Official Site

Have an unsafe medication, device, or food to report?

Filing a report with the FDA is free and takes a few minutes. Consumer reports drive future recalls and help the agency identify safety patterns.

How to report to FDA →
68,659 recalls
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular...
Cardiac Devices·13,297 affected·Nov 3, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Soft...
Diagnostic Devices·200 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
Medical Devices·15 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neuro...
Medical Implants·13,297 affected·Nov 3, 2015
RecallFDA
Diagnostic Hybrids, Inc.
MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 comple...
Diagnostic Devices·107 affected·Nov 3, 2015
CriticalFDA
Specialty Commodities, Inc.
Heartland Flax Meal, Net Wt. 50 lbs.
Food·340 affected·Nov 2, 2015
High RiskFDA
Bake Rite Rolls Divison Of Northeast Foods
100% Whole Grain Hot Dog Rolls
Food·6,852 affected·Nov 2, 2015
RecallFDA
Mylan Institutional, Inc. (d.b.a. Udl Laboratories)
Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pha...
Oral Drugs·4,609 affected·Nov 2, 2015
High RiskFDA
Synthes (usa) Products Llc
2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and...
Medical Devices·229 affected·Nov 2, 2015
High RiskFDA
Trumpf Medical Systems, Inc.
Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
Surgical Devices·20,713 affected·Nov 2, 2015
High RiskFDA
The Anspach Effort, Inc.
Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.
Surgical Devices·50 affected·Nov 2, 2015
CriticalFDA
Insulet Corporation
OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended ...
Diabetes Devices·5,179 affected·Nov 2, 2015
CriticalFDA
Insulet Corporation
OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intende...
Diabetes Devices·26,230 affected·Nov 2, 2015
High RiskFDA
Norpac Foods, Inc. (plant #8)
IQF FLAV-R-PAC Cut Wax Beans, there are 12/2 lbs. bags per case. Catalog # 07570. Product was distributed to Food Service accounts....
Frozen Food·792 affected·Oct 30, 2015
RecallFDA
Avantor Performance Materials Inc
Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 2...
Drugs·265 affected·Oct 30, 2015
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific...
Diagnostic Devices·23 affected·Oct 30, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
Medical Devices·17 affected·Oct 30, 2015
CriticalFDA
Green Organic Vegetables Incorporated
Natures Promise Organic Edamame in Pod, 16 oz., UPC 68826702124. Product is frozen.
Frozen Food·1,081 affected·Oct 29, 2015
CriticalFDA
Green Organic Vegetables Incorporated
Natures Promise Organic Shelled Edamame, 16 oz., UPC 68826712764. Product is frozen.
Frozen Food·1,084 affected·Oct 29, 2015
High RiskFDA
Hormel Foods Corporation
Skippy Creamy 25% Less Fat Reduced Fat Peanut Butter Spread Net Wt. 16.3 OZ (1 lb 0.3 OZ) 462g in plastic jars, UPC: 037600105002
Dairy·153 affected·Oct 29, 2015
RecallFDA
Pq Corporation
EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forg...
Drugs·41,650 affected·Oct 29, 2015
High RiskFDA
Amerisource Health Services
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packag...
Oral Drugs·2,784 affected·Oct 29, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
Medical Devices·323 affected·Oct 29, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT Computed Tomography X-ray system
Medical Devices·31 affected·Oct 29, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT Computed Tomography X-ray system
Medical Devices·51 affected·Oct 29, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray system
Medical Devices·177 affected·Oct 29, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Medical Devices·7 affected·Oct 29, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
Medical Devices·133 affected·Oct 29, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core Computed Tomography X-ray system
Medical Devices·135 affected·Oct 29, 2015
CriticalFDA
East-west Specialty Sauces, Inc.
East-West Classic Sweet & Sour Sauce, 12 fl. Oz., Glass bottle, 6/case, Refrigerate after opening, Distributed by East-West Specialty Sau...
Food·404 affected·Oct 28, 2015
CriticalFDA
Southeastern Grocers Llc
Bakery Oatmeal Raisin Cookies packaged in clear plastic clamshell container, 12-count, 18-count, and 20-count
Bakery & Grains·21,600 affected·Oct 28, 2015
CriticalFDA
Southeastern Grocers Llc
Bakery Variety Pack Cookies Containing Oatmeal Rasin Cookies packaged in clear plastic clamshell container, 12-count, 18-count, and 20-count
Bakery & Grains·21,600 affected·Oct 28, 2015
High RiskFDA
Csfpdx, Llc
Labeled "CSFISHERY COMMUNITY SUPPORTED FISHERY Wild Albacore Tuna, 64 oz.., Ingredients: Oregon Albacore Tuna, Sea Salt" Label is bla...
Seafood·142 affected·Oct 28, 2015
RecallFDA
Frozen Specialties Inc
FOOD LION CHEESE microwaveable crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEE...
Dairy·5,515 affected·Oct 28, 2015
CriticalFDA
Southeastern Grocers Llc
Cookie Platter Containing Oatmeal Rasin Cookies packaged in plastic container, 48-count and 36-count
Bakery & Grains·21,600 affected·Oct 28, 2015
RecallFDA
Frozen Specialties Inc
FOOD LION CHEESE crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CON...
Dairy·10,980 affected·Oct 28, 2015
CriticalFDA
Sanofi-aventis U.s. Llc
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefill...
Injectable Drugs·383,900 affected·Oct 28, 2015
CriticalFDA
Sanofi-aventis U.s. Llc
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefil...
Injectable Drugs·159,000 affected·Oct 28, 2015
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm ...
Medical Implants·478 affected·Oct 28, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo Imaging VB36D_HF02. Radiological image processing system.
Medical Devices·3 affected·Oct 28, 2015
High RiskFDA
Masimo Corporation
rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DC...
Medical Devices·3,476 affected·Oct 28, 2015
High RiskFDA
Medtronic Perfusion Systems
Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and co...
Medical Devices·496 affected·Oct 28, 2015
High RiskFDA
Baylis Medical Corp *
ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infus...
Surgical Devices·433 affected·Oct 28, 2015
High RiskFDA
Quest Medical, Inc.
Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Deliv...
Medical Devices·18,761 affected·Oct 28, 2015
High RiskFDA
Herrs Foods Inc
Herr's Sour Cream & Onion Flavored Potato Chips
Dairy·231,120 affected·Oct 27, 2015
CriticalFDA
Helados La Tapatia, Inc.
Helados La Tapatia Creamy Fruit Bars; All Natural Rice Arroz; Net Wt. 3 FL oz; UPC 6 34242 20008 1; INGREDIENTS FOR MILK BARS: ICE...
Dairy·0 affected·Oct 27, 2015
CriticalFDA
Helados La Tapatia, Inc.
Helados La Tapatia Creamy Fruit Bars; Strawberry Cream flavor; Net Wt. 3 FL oz; UPC 6 34242 20001 2; INGREDIENTS FOR MILK BARS: I...
Dairy·326 affected·Oct 27, 2015
CriticalFDA
Helados La Tapatia, Inc.
Helados La Tapatia Creamy Fruit Bars; Chocolate; Net Wt. 3 FL oz; UPC 6 34242 20003 6; INGREDIENTS FOR MILK BARS: ICE CREAM MIX (M...
Dairy·0 affected·Oct 27, 2015