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
High RiskFDA
Baxter Healthcare Corp.
The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system...
Medical Devices·75 affected·Oct 16, 2013
CriticalFDA
B. Braun Medical Inc
Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Si...
Injectable Drugs·18,936 affected·Oct 15, 2013
High RiskFDA
Vistapharm, Inc.
Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo...
Oral Drugs·27,788 affected·Oct 15, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Ma...
Medical Implants·44 affected·Oct 15, 2013
High RiskFDA
Teleflex Medical
Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube.
Medical Devices·6,200 affected·Oct 15, 2013
High RiskFDA
Innovative Labs, Llc
Terrain Zyme LGS-Zyme (Z-12), Enzyme-Based Multivitamin & Amino Acid Dietary Supplement, packaged as 120 capsules per bottle. Distribute...
Supplements·579 affected·Oct 14, 2013
High RiskFDA
Innovative Labs, Llc
Terrain Zyme Myco-Zyme (Z-13), Enzyme-Based Herbal Dietary Supplement, packaged as 90 capsules per bottle. Distributed by Apex Energetic...
Supplements·1,256 affected·Oct 14, 2013
High RiskFDA
Synthes (usa) Products Llc
Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part o...
Medical Devices·55 affected·Oct 14, 2013
High RiskFDA
Philips Medical Systems, Inc.
Philips Multi Diagnost Eleva II
Diagnostic Devices·238 affected·Oct 14, 2013
High RiskFDA
Philips Healthcare Informatics, Inc.
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardwa...
Medical Devices·71 affected·Oct 14, 2013
High RiskFDA
Restoration Robotics
Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is app...
Medical Devices·515 affected·Oct 13, 2013
High RiskFDA
Restoration Robotics
ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline ...
Medical Devices·515 affected·Oct 13, 2013
High RiskFDA
Restoration Robotics
ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm ...
Medical Devices·515 affected·Oct 13, 2013
High RiskFDA
Metagenics, Inc.
Spectrazyme, 180 count, 60 count, 12 bottles/case, 20000 tablets/box, 14000 capsules/pail.
Food·1,171,300 affected·Oct 11, 2013
High RiskFDA
Abbott Nutrition
Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDITIONAL IRON MAY BE NECESSARY ADD ONLY TO HUMAN MILK - DO NOT...
Dairy·31,056 affected·Oct 11, 2013
CriticalFDA
Best Value Inc
PRAN TURMERIC POWDER 400 GM plastic bag
Food·10 affected·Oct 11, 2013
CriticalFDA
Yoders Country Market
Custom made gift boxes containing: HONEY ROASTED PEANUTS, Net Wt. 11 oz. (311G), Dist.By: Dutch Valley Food Distributors, Inc. Myerstown...
Food·24 affected·Oct 11, 2013
High RiskFDA
Teva Pharmaceuticals Usa
Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parent...
Injectable Drugs·13,520 affected·Oct 11, 2013
High RiskFDA
Hospira Inc.
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. ND...
Drugs·65,109 affected·Oct 11, 2013
High RiskFDA
Sandoz Inc
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
Oral Drugs·2,491 affected·Oct 11, 2013
High RiskFDA
Hospira Inc.
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx ...
Injectable Drugs·70,450 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2....
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2....
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
PRESSFIT FEM ST FX 16 X 1
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3....
Medical Devices·7,044,680 affected·Oct 11, 2013
CriticalFDA
Codman & Shurtleff, Inc.
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial o...
Surgical Devices·7,983 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.
Medical Implants·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
CPT 12/14 COCR (various sizes)
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 5...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE 3.5 COMP PLT, 8 HOLE 3.5 COMP PLT, 9 HOLE 3....
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL DORSAL ULNA PLT, and PROXIMAL MEDIAL TIBIAL 4.
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
ZIMTRON 6 DEG 22 HEADS
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
ASIA ONE-PIECE LAG SCREW
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543.
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VE...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Ge Healthcare, Llc
GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging an...
Cardiac Devices·710 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY ACET SHELL 42MM O TRILOGY ACET SHELL 44MM O TR...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Becton Dickinson & Co.
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc...
Diagnostic Devices·33 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NE...
Medical Devices·7,044,680 affected·Oct 11, 2013