Skip to main content
High RiskFDA
Zimmer, Inc.
Gender Solutions" Patello-Femoral Component
Medical Devices·5,103 affected·Aug 30, 2013
High RiskFDA
Zimmer, Inc.
NexGen¿ Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ ...
Medical Devices·604,064 affected·Aug 30, 2013
High RiskFDA
Blythedale Farm Inc.
Blythedale Farm Camembert Vermont, 7 oz wrapped disc in plastic cup UPC Code: 762713669027
Food·9 affected·Aug 29, 2013
High RiskFDA
The Seafood Exchange Of Fla
H-E-B Jumbo Butterfly Shrimp-10.5 oz Box, 20 units per case
Dairy·190 affected·Aug 29, 2013
High RiskFDA
Blythedale Farm Inc.
Blythedale Farm Farmstead Brie, 1 lb white wrapped disc UPC Code:
Food·143 affected·Aug 29, 2013
High RiskFDA
Blythedale Farm Inc.
Blythedale Farm Vermont Brie, 7 oz. wrapped disc in plastic cup UPC Code: 762713669010
Food·11,678 affected·Aug 29, 2013
High RiskFDA
Dr. Reddy's Laboratories, Inc.
IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bri...
Oral Drugs·18,852 affected·Aug 29, 2013
High RiskFDA
Hospira Inc.
5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01
Injectable Drugs·86,400 affected·Aug 29, 2013
High RiskFDA
Procter & Gamble Co
Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg, Dextromethorphan HBr 30mg, Doxylamine succinate 12.5...
Drugs·11,337 affected·Aug 29, 2013
High RiskFDA
Carestream Health Inc.
CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY ...
Medical Devices·364 affected·Aug 29, 2013
High RiskFDA
Carestream Health Inc.
DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14...
Medical Devices·190 affected·Aug 29, 2013
High RiskFDA
Integra Lifesciences Corp.
Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device, designed to pr...
Medical Devices·37 affected·Aug 29, 2013
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorpor...
Medical Devices·8,528 affected·Aug 29, 2013
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodial...
Medical Devices·508,029 affected·Aug 29, 2013
High RiskFDA
Biomet 3i, Llc
BIOMET 3i Endosseous Dental Implant.
Medical Implants·34,744 affected·Aug 29, 2013
High RiskFDA
Vital Diagnostics, Inc.
Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and...
Diagnostic Devices·213 affected·Aug 29, 2013
High RiskFDA
Boston Scientific Crm Corp
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models ...
Medical Implants·38,500 affected·Aug 29, 2013
High RiskFDA
Steris Corporation
Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The inte...
Medical Devices·266 affected·Aug 29, 2013
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS¿ Fluid M...
Surgical Devices·368 affected·Aug 29, 2013
High RiskFDA
Premier Foods, Llc
Artichoke Pecorino Sauce, 16 fl. oz., 12 jars/case
Food·5,880 affected·Aug 28, 2013
High RiskFDA
Stonyfield Farm
Stonyfield Organic O Soy Yogurt Strawberry , 6 oz.cup, Refrigerated USPC code: 05215900603
Dairy·140 affected·Aug 28, 2013
High RiskFDA
Zimmer, Inc.
Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used wit...
Medical Devices·2,632 affected·Aug 28, 2013
High RiskFDA
Camlog Usa
C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are inten...
Medical Implants·6 affected·Aug 28, 2013
High RiskFDA
Camlog Usa
C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only ¿5.0GH 0.8 inkl HS Product Usage: Endosseous dental i...
Medical Implants·3 affected·Aug 28, 2013
High RiskFDA
Spinefrontier, Inc.
S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusi...
Surgical Devices·67 affected·Aug 28, 2013
High RiskFDA
Globus Medical, Inc.
Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps th...
Medical Devices·193 affected·Aug 28, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified ...
Medical Devices·76 affected·Aug 28, 2013
High RiskFDA
Zimmer, Inc.
VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for tota...
Medical Devices·12,866 affected·Aug 28, 2013
High RiskFDA
Snoqualmie Falls Candy Factory, Llc
Almond Brittle's label is read in parts:"***ALMOND BRITTLE***INGREDIENTS: Sugar, corn syrup, almonds, brown sugar, butter (cream, salt), ...
Dairy·0 affected·Aug 27, 2013
High RiskFDA
Snoqualmie Falls Candy Factory, Llc
Coconut Peanut Brittle's label is read in parts:"***COCONUT PEANUT BRITTLE***INGREDIENTS: Coconut (preserved with sodium metabisulfate), ...
Dairy·0 affected·Aug 27, 2013
High RiskFDA
Snoqualmie Falls Candy Factory, Llc
Coconut Brittle's is labeled in parts: "***COCONUT BRITTLE***INGREDIENTS: Coconut (preserved with metabisulfate), white sugar, glucose, ...
Dairy·0 affected·Aug 27, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, T...
Medical Devices·16 affected·Aug 27, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 381...
Medical Devices·46 affected·Aug 27, 2013
High RiskFDA
Siemens Healthcare Diagnostics
T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IM...
Diagnostic Devices·2,201 affected·Aug 27, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38...
Medical Devices·80 affected·Aug 27, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38...
Medical Devices·45 affected·Aug 27, 2013
High RiskFDA
Clark Laboratories, Inc. (dba,trinity Biotech Usa)
Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidu...
Diagnostic Devices·38 affected·Aug 27, 2013
High RiskFDA
Siemens Healthcare Diagnostics
T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tes...
Diagnostic Devices·4,695 affected·Aug 27, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 3...
Medical Devices·8 affected·Aug 27, 2013
High RiskFDA
Leiter's Pharmacy
Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., #...
Drugs·728 affected·Aug 26, 2013
High RiskFDA
Leiter's Pharmacy
Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pha...
Injectable Drugs·56 affected·Aug 26, 2013
High RiskFDA
Leiter's Pharmacy
Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park A...
Drugs·810 affected·Aug 26, 2013
High RiskFDA
Pharmacy Creations
Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ.
Injectable Drugs·50 affected·Aug 26, 2013
High RiskFDA
Leiter's Pharmacy
Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose,...
Drugs·265 affected·Aug 26, 2013
High RiskFDA
Pharmacy Creations
EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Creations, Randolph, NJ 07869
Injectable Drugs·75 affected·Aug 26, 2013
High RiskFDA
Biomet 3i, Llc
Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***Bell...
Medical Implants·10,454 affected·Aug 26, 2013
High RiskFDA
Snug Seat Inc
Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking a...
Medical Devices·726 affected·Aug 26, 2013
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Produ...
Medical Devices·80 affected·Aug 26, 2013