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

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68,659 recalls
CriticalFDA
Cooperstown Cheese Company, Llc
Roasted Garlic and Black Peppercorns. All package sizes are subject to the recall and the plant number on the label is 36-8524.
Food·7 affected·Oct 6, 2017
High RiskFDA
Avkare Inc.
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Ma...
Oral Drugs·274 affected·Oct 6, 2017
High RiskFDA
New Reliance Trading, Inc.
No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by NEW RELIANCE TRADING, INC., 5563 59th St., Mas...
Topical Drugs·513 affected·Oct 6, 2017
High RiskFDA
Kiriko, Llc.
A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, info@a1sl...
Oral Drugs·700 affected·Oct 6, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Brilliance 64 computed tomography x-ray system
Medical Devices·1,801 affected·Oct 6, 2017
High RiskFDA
Halyard Health, Inc
Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
Medical Devices·52,660 affected·Oct 6, 2017
High RiskFDA
Allen Medical Systems
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
Surgical Devices·161 affected·Oct 6, 2017
High RiskFDA
Halyard Health, Inc
Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
Medical Devices·52,660 affected·Oct 6, 2017
High RiskFDA
Halyard Health, Inc
Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.
Medical Devices·52,660 affected·Oct 6, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Ingenuity Core computed tomography x-ray system
Medical Devices·0 affected·Oct 6, 2017
High RiskFDA
Halyard Health, Inc
Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 vials per kit, 20 kits per case.
Medical Devices·52,660 affected·Oct 6, 2017
High RiskFDA
Halyard Health, Inc
Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 vials per kit, 20 kits per case.
Medical Devices·52,660 affected·Oct 6, 2017
High RiskFDA
Halyard Health, Inc
NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 vials per kit, 2...
Medical Devices·52,660 affected·Oct 6, 2017
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. ...
Medical Devices·173,375 affected·Oct 6, 2017
High RiskFDA
Allen Medical Systems
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
Surgical Devices·161 affected·Oct 6, 2017
RecallFDA
Blue Line Food Service Distribution
Deep Dish pre mix dough
Food·2,011 affected·Oct 5, 2017
High RiskFDA
Purdue Pharma, Lp
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
Drugs·3,997 affected·Oct 5, 2017
CriticalFDA
Monteris Medical Corp
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Surgical Devices·52 affected·Oct 5, 2017
High RiskFDA
Teleflex Medical
WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
Medical Devices·13,710 affected·Oct 5, 2017
High RiskFDA
Ge Healthcare, Llc
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
Medical Devices·2 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
RESONATE X4 CRT-D, Model G447, Sterile.
Medical Devices·11 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
RESONATE EL ICD VR, Model D432, Sterile.
Medical Devices·5 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
MOMENTUM X4 CRT-D, Model G138, Sterile.
Medical Devices·4 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
RESONATE EL ICD DR, Model D433, Sterile.
Medical Devices·12 affected·Oct 4, 2017
High RiskFDA
Boston Scientific Corporation
VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with he...
Cardiac Devices·4 affected·Oct 4, 2017
High RiskFDA
Ge Healthcare, Llc
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in cont...
Medical Devices·28 affected·Oct 4, 2017
High RiskFDA
Draegar Medical Systems, Inc.
INFINITY DUAL HEMO MCable Pod
Medical Devices·2,760 affected·Oct 4, 2017
Medium RiskFDA
Dr. Reddy's Laboratories, Inc.
Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by...
Oral Drugs·569,376 affected·Oct 3, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
Medical Devices·21,350 affected·Oct 3, 2017
High RiskFDA
Arthrex, Inc.
iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, ...
Medical Devices·20 affected·Oct 3, 2017
High RiskFDA
Zimmer Biomet, Inc.
Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
Medical Devices·8 affected·Oct 3, 2017
High RiskFDA
Zimmer Biomet, Inc.
Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040
Medical Devices·127 affected·Oct 3, 2017
High RiskFDA
Zimmer Biomet, Inc.
Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: ...
Medical Devices·457 affected·Oct 3, 2017
CriticalFDA
Allen's Blueberry Freezer, Inc.
Allen's Blueberries IQF Wild Blueberries, 30 lbs. corrugated box
Produce·45,330 affected·Oct 2, 2017
High RiskFDA
Friendly Fruit Market Dba Sid Wainer & Son
Sid Wainer & Son Jansal Valley brand Dried Chili De Arbol Peppers,packaged in a plastic clamshell container 1 ounce size
Food·7 affected·Oct 2, 2017
High RiskFDA
Unichem Pharmaceuticals Usa Inc
Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne,...
Oral Drugs·96,876 affected·Oct 2, 2017
High RiskFDA
Edwards Lifesciences, Llc
Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart...
Cardiac Devices·198 affected·Oct 2, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cro...
Medical Devices·6 affected·Oct 2, 2017
High RiskFDA
Beckman Coulter Inc.
AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL...
Diagnostic Devices·268 affected·Oct 2, 2017
CriticalFDA
Greencore Usa, Llc
Hannaford Ham Salad Club Roll, 5.1 oz
Produce·358 affected·Sep 29, 2017
CriticalFDA
Greencore Usa, Llc
Hannaford Egg Salad Club Roll 5.1 oz
Produce·653 affected·Sep 29, 2017
CriticalFDA
Greencore Usa, Llc
(1) Walgreens NICE Egg Salad on White Bread, 6.1 oz (2) Turkey Hill Fresh Selects Egg salad on Homestyle Bread,4.7 oz (3)Target Egg ...
Meat & Poultry·2,598 affected·Sep 29, 2017
High RiskFDA
Pinnacle Food Group, Llc
Birds Eye Baby Sweet Peas, Net Wt. 13 oz. (369g ), Keep Frozen. UPC 14500-02253.
Frozen Food·24,690 affected·Sep 29, 2017
High RiskFDA
Beyond Better Foods Llc
ENLIGHTENED THE GOOD-FOR-YOU ICE CREAM 60 CALORIES PER SERVING PINA COLADA MORE PROTEIN. LESS SUGAR 1 PINT LOW FAT ICE CREAM, UPC 8 52109...
Dairy·4,756 affected·Sep 29, 2017
CriticalFDA
Dean Foods, Inc.
Tampico Tropical Punch packaged in 1 gallon plastic jugs
Food·1,804 affected·Sep 29, 2017
CriticalFDA
Tai Foong Usa Inc
Costco item # 1052939, Royal Asia brand Shrimp Wonton Noodle Soup, 6 bowls per case. Net weight 3.94lb (1.79kg) 63oz. UPC 8 77971 00536 ...
Seafood·7,793 affected·Sep 29, 2017
CriticalFDA
Greencore Usa, Llc
(1)Turkey Hill Fresh Selects Ham salad on Homestyle Bread, 4.9 oz (2)American Food and Vending Enza Choice Ham Salad on White Bread, 4.7...
Meat & Poultry·316 affected·Sep 29, 2017
High RiskFDA
Abbott Laboratories, Inc
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
Medical Devices·34 affected·Sep 29, 2017