Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Baxter Healthcare Corp.
Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day INFUSOR 2 ml/h S...
Medical Devices·601,230 affected·Jun 7, 2013
High RiskFDA
Becton Dickinson & Co.
BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle S...
Medical Devices·911 affected·Jun 6, 2013
High RiskFDA
Becton Dickinson & Co.
BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 ...
Medical Devices·92 affected·Jun 6, 2013
High RiskFDA
Carestream Health, Inc.
Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
Medical Devices·180 affected·Jun 6, 2013
High RiskFDA
Sybron Dental Specialties
AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a c...
Medical Devices·1,091 affected·Jun 6, 2013
High RiskFDA
Endogastric Solutions Inc
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of sy...
Medical Devices·5,192 affected·Jun 6, 2013
High RiskFDA
Becton Dickinson & Co.
BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Be...
Medical Devices·42 affected·Jun 6, 2013
High RiskFDA
Becton Dickinson & Co.
BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, a...
Medical Devices·106 affected·Jun 6, 2013
High RiskFDA
Becton Dickinson & Co.
BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Com...
Medical Devices·163 affected·Jun 6, 2013
High RiskFDA
Becton Dickinson & Co.
BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 297840, packaged in cartons of 20 plates, labeled in part ***...
Medical Devices·92 affected·Jun 6, 2013
High RiskFDA
Invacare Corporation
Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.
Medical Devices·166,230 affected·Jun 4, 2013
High RiskFDA
Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization pro...
Medical Devices·2,447 affected·Jun 4, 2013
High RiskFDA
Baxa Corporation
ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished s...
Medical Devices·753 affected·Jun 4, 2013
High RiskFDA
Mesa Laboratories, Inc., Bozeman Manufacturing Facility
Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
Medical Devices·865 affected·Jun 4, 2013
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay...
Medical Devices·5,480 affected·Jun 3, 2013
High RiskFDA
Synthes (usa) Products Llc
Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is...
Medical Devices·119 affected·May 31, 2013
High RiskFDA
Greatbatch Medical
Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane ...
Medical Devices·550 affected·May 31, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for...
Medical Devices·7 affected·May 30, 2013
High RiskFDA
Exactech, Inc.
Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other d...
Medical Devices·57 affected·May 30, 2013
CriticalFDA
Stryker Spine
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline...
Medical Devices·1,536 affected·May 30, 2013
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
Medical Devices·4,691 affected·May 30, 2013
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
Medical Devices·4,691 affected·May 30, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelera...
Medical Devices·8 affected·May 29, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended u...
Medical Devices·1,956 affected·May 29, 2013
High RiskFDA
Medtronic Sofamor Danek Usa Inc
INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopa...
Medical Devices·22,936 affected·May 28, 2013
High RiskFDA
Medtronic Sofamor Danek Usa Inc
INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 o...
Medical Devices·2,090 affected·May 28, 2013
High RiskFDA
Medtronic Sofamor Danek Usa Inc
INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orth...
Medical Devices·1,319 affected·May 28, 2013
High RiskFDA
Medtronic Sofamor Danek Usa Inc
INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopa...
Medical Devices·4,885 affected·May 28, 2013
High RiskFDA
Elekta, Inc.
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of...
Medical Devices·472 affected·May 28, 2013
High RiskFDA
Abbott Medical Optics, Inc.
STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95...
Medical Devices·1,882 affected·May 28, 2013
High RiskFDA
Medtronic Sofamor Danek Usa Inc
INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 ort...
Medical Devices·400 affected·May 28, 2013
High RiskFDA
Dental Ez Stardental Division
StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
Medical Devices·3,560 affected·May 28, 2013
High RiskFDA
Abbott Medical Optics, Inc.
STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer...
Medical Devices·1,882 affected·May 28, 2013
RecallFDA
Boston Scientific Corporation
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation ...
Medical Devices·91 affected·May 28, 2013
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodi...
Medical Devices·725 affected·May 24, 2013
High RiskFDA
Sotera Wireless, Inc.
ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinic...
Medical Devices·75 affected·May 23, 2013
High RiskFDA
Zimmer, Inc.
Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorl...
Medical Devices·722 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to...
Medical Devices·334,520 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product Usage: Protection System and are intende...
Medical Devices·34,640 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to...
Medical Devices·7,960 affected·May 23, 2013
High RiskFDA
Prism Medical Services Usa
BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for ex...
Medical Devices·5 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; Product Usage: Protection System and are inte...
Medical Devices·21,660 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended...
Medical Devices·48,040 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use; Product Usage: Protection System and are intended...
Medical Devices·9,930 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO; single use. Product Usage: Protection System and are ...
Medical Devices·1,980 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single use; Product Usage: Protection System and are intended ...
Medical Devices·3,980 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are inten...
Medical Devices·88,040 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Product Usage: Protection System and are in...
Medical Devices·25,770 affected·May 23, 2013