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All Product Recalls
49,195 recalls from FDA (high severity)
High RiskFDA
Nature's Value Inc.
Vitacost Mega Spectrum Enzyme, packaged with 180 Vegetarian Capsules, UPC Code: 84419701519. Manufactured for Vitacost Lexington, NC 27295
Food796,800 affectedOct 17, 2013
High RiskFDA
Baxter Healthcare Corp
15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
Medical Devices3,085,080 affectedOct 17, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Sl...
Diagnostic Devices548,663 affectedOct 17, 2013
High RiskFDA
Philips Medical Systems North America Inc.
EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
Diagnostic Devices306 affectedOct 17, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemis...
Diagnostic Devices19,368 affectedOct 17, 2013
High RiskFDA
Zimmer, Inc.
Trabecular Metal" Reverse Shoulder System
Medical Devices73,002 affectedOct 17, 2013
High RiskFDA
Spacelabs Healthcare, Llc
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube...
Medical Devices54 affectedOct 17, 2013
High RiskFDA
Bausch & Lomb Surgical, Inc.
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the v...
Medical Implants336 affectedOct 16, 2013
High RiskFDA
Microgenics Corp
Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by ...
Diagnostic Devices370 affectedOct 16, 2013
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 Devices75 affectedOct 16, 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 Drugs27,788 affectedOct 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 Implants44 affectedOct 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 Devices6,200 affectedOct 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...
Supplements579 affectedOct 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...
Supplements1,256 affectedOct 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 Devices55 affectedOct 14, 2013
High RiskFDA
Philips Medical Systems, Inc.
Philips Multi Diagnost Eleva II
Diagnostic Devices238 affectedOct 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 Devices71 affectedOct 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 Devices515 affectedOct 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 Devices515 affectedOct 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 Devices515 affectedOct 13, 2013
High RiskFDA
Metagenics, Inc.
Spectrazyme, 180 count, 60 count, 12 bottles/case, 20000 tablets/box, 14000 capsules/pail.
Food1,171,300 affectedOct 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...
Dairy31,056 affectedOct 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 Drugs13,520 affectedOct 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...
Drugs65,109 affectedOct 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 Drugs2,491 affectedOct 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 Drugs70,450 affectedOct 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 Devices7,044,680 affectedOct 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 Devices7,044,680 affectedOct 11, 2013
High RiskFDA
Zimmer, Inc.
PRESSFIT FEM ST FX 16 X 1
Medical Devices7,044,680 affectedOct 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 Devices7,044,680 affectedOct 11, 2013
High RiskFDA
Zimmer, Inc.
12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M)
Medical Devices7,044,680 affectedOct 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 Implants7,044,680 affectedOct 11, 2013
High RiskFDA
Zimmer, Inc.
CPT 12/14 COCR (various sizes)
Medical Devices7,044,680 affectedOct 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 Devices7,044,680 affectedOct 11, 2013
High RiskFDA
Zimmer, Inc.
Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
Medical Devices7,044,680 affectedOct 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 Devices7,044,680 affectedOct 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 Devices7,044,680 affectedOct 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 Devices7,044,680 affectedOct 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 Devices7,044,680 affectedOct 11, 2013
High RiskFDA
Zimmer, Inc.
ZIMTRON 6 DEG 22 HEADS
Medical Devices7,044,680 affectedOct 11, 2013
High RiskFDA
Zimmer, Inc.
ASIA ONE-PIECE LAG SCREW
Medical Devices7,044,680 affectedOct 11, 2013
High RiskFDA
Zimmer, Inc.
HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
Medical Devices7,044,680 affectedOct 11, 2013
High RiskFDA
Zimmer, Inc.
CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
Medical Devices7,044,680 affectedOct 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 Devices7,044,680 affectedOct 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 Devices7,044,680 affectedOct 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 Devices7,044,680 affectedOct 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 Devices7,044,680 affectedOct 11, 2013