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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur med...
Respiratory Devices·503 affected·Jun 11, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur m...
Respiratory Devices·42 affected·Jun 11, 2013
High RiskFDA
Integra Lifesciences Corp.
Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft...
Respiratory Devices·109 affected·Jun 11, 2013
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur m...
Respiratory Devices·16 affected·Jun 11, 2013
High RiskFDA
Ge Healthcare It
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare...
Diagnostic Devices·623 affected·Jun 11, 2013
High RiskFDA
Zimmer, Inc.
Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaed...
Medical Devices·1 affected·Jun 11, 2013
High RiskFDA
Angiodynamics, Inc
AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RI...
Surgical Devices·13 affected·Jun 11, 2013
High RiskFDA
Philips Healthcare Inc.
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile d...
Diagnostic Devices·240 affected·Jun 11, 2013
High RiskFDA
Healthmaxx Global Inc.
MAX Brand Bio-Cell Collagen II, 100 Count Softgels Product labeling reads in part:"MAX Bio-Cell CollagenII Dietary Supplement 100 Soft...
Supplements·9,069 affected·Jun 10, 2013
High RiskFDA
Healthmaxx Global Inc.
Hyper II DHA/EPA, 100 Count Softgels. Product labeling reads in part:"Hyper II DHA/EPA Refined Deep Sea Fish Oil 50% DHA - 30% EPA***D...
Seafood·2,863 affected·Jun 10, 2013
High RiskFDA
Zimmer, Inc.
Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD ...
Medical Devices·70,986 affected·Jun 10, 2013
High RiskFDA
Steritec Products Mfc. Co., Inc.
Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicato...
Medical Devices·8,200 affected·Jun 10, 2013
High RiskFDA
Steritec Products Mfc. Co., Inc.
Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ EZTest Steam Biological Indicator...
Medical Devices·200 affected·Jun 10, 2013
High RiskFDA
Zimmer, Inc.
Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TASP PS L 3-...
Medical Devices·70,986 affected·Jun 10, 2013
High RiskFDA
Steritec Products Mfc. Co., Inc.
Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biolo...
Medical Devices·5,000 affected·Jun 10, 2013
High RiskFDA
Steritec Products Mfc. Co., Inc.
Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 The Smart-R...
Medical Devices·15,300 affected·Jun 10, 2013
High RiskFDA
Staar Surgical Co.
nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by c...
Medical Implants·3,361 affected·Jun 10, 2013
High RiskFDA
Steritec Products Mfc. Co., Inc.
Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE ...
Medical Devices·360 affected·Jun 10, 2013
High RiskFDA
Biomet 3i, Llc
Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower j...
Medical Implants·215 affected·Jun 10, 2013
High RiskFDA
Baxter Healthcare Corp.
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Medical Devices·273,835 affected·Jun 10, 2013
High RiskFDA
Steritec Products Mfc. Co., Inc.
EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biologic...
Medical Devices·14,900 affected·Jun 10, 2013
High RiskFDA
Zimmer, Inc.
Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A...
Medical Devices·70,986 affected·Jun 10, 2013
High RiskFDA
Steritec Products Mfc. Co., Inc.
Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR S...
Medical Devices·3,535 affected·Jun 10, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the acceptance, transfer, ...
Medical Devices·9 affected·Jun 10, 2013
High RiskFDA
Steritec Products Mfc. Co., Inc.
Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read ...
Medical Devices·10,170 affected·Jun 10, 2013
High RiskFDA
Zimmer, Inc.
Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6...
Medical Devices·70,986 affected·Jun 10, 2013
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical en...
Surgical Devices·30 affected·Jun 8, 2013
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical e...
Surgical Devices·30 affected·Jun 8, 2013
High RiskFDA
Sagent Pharmaceuticals Inc
VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SA...
Injectable Drugs·831,950 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·23 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·22 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compa...
Medical Devices·26 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90597003110 Articular Surface CR ART SURF 34/STR YEL 10MM, Rx,...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile; 65595201202 Femur CR-FLEX P...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Steril...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·30 affected·Jun 7, 2013
High RiskFDA
Baxter Healthcare Corp.
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
Medical Devices·3,255,096 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-FLEX OPT FEM B-R Rx Sterile; Used in total knee arthropl...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM,...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·25 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·24 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compa...
Medical Devices·26 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, S...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femur CR PRC FEM COMP SIZE CMR Rx, Sterile; 00597001403 Fem...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Baxter Healthcare Corp.
Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.
Medical Devices·3,255,096 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL POLY PAT COMP MICRO 29DIA, Rx, Sterile; 005...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 00597103112 Provisional CR ART SURF PROV 34/STR YEL 12, Rx, Ste...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·22 affected·Jun 7, 2013