Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
CriticalFDA
Ge Healthcare, Llc
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM/CT 670 syste...
Medical Devices·213 affected·Jun 13, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitatively measure protei...
Medical Devices·19,438 affected·Jun 12, 2013
High RiskFDA
Accelerated Care Plus Corporation
Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germa...
Medical Devices·1,001 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicy...
Medical Devices·15,492 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP Slides quantitatively measure alkaline phosph...
Medical Devices·183,267 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 VITROS PHOS Slides quantitatively measure phosp...
Medical Devices·81,382 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 81...
Medical Devices·70,125 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) concentratio...
Medical Devices·16,583 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and packaged as 90 slides/pack catalog number 1632...
Medical Devices·62,039 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921...
Medical Devices·101,976 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VITROS DGXN Slides quantitatively measure digoxi...
Medical Devices·24,857 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total...
Medical Devices·175,689 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 800...
Medical Devices·11,135 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 82...
Medical Devices·62,039 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 16...
Medical Devices·74,792 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (...
Medical Devices·231,112 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396 VITROS ECO2 Slides quantitatively measure total...
Medical Devices·205,534 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protei...
Medical Devices·31,395 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927 VITROS URIC Slides quantitatively measure uric ...
Medical Devices·85,646 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 13...
Medical Devices·7,926 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitatively measure creat...
Medical Devices·364,752 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 1924...
Medical Devices·37,525 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VITROS CRP Slides quantitatively measure C-reacti...
Medical Devices·86,522 affected·Jun 12, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8...
Medical Devices·28,739 affected·Jun 12, 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
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
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
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
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