Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of...
Medical Devices·62 affected·Jul 19, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Pr...
Medical Devices·179 affected·Jul 18, 2013
High RiskFDA
Vital Signs Devices, A Ge Healthcare Company
Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Ca...
Medical Devices·12,239 affected·Jul 18, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxid...
Medical Devices·217 affected·Jul 17, 2013
High RiskFDA
Integra Limited
Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggle...
Medical Devices·65 affected·Jul 17, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Steri...
Medical Devices·13,223 affected·Jul 17, 2013
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01...
Medical Devices·758 affected·Jul 17, 2013
High RiskFDA
Hospira Inc.
Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Fo...
Medical Devices·3,560 affected·Jul 17, 2013
High RiskFDA
Beckman Coulter Inc.
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for d...
Medical Devices·68,116 affected·Jul 17, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstructi...
Medical Devices·506 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & ...
Medical Devices·8 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & ...
Medical Devices·6 affected·Jul 16, 2013
RecallFDA
Zoll Circulation, Inc.
Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembl...
Medical Devices·161 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & C...
Medical Devices·7 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 mm, WALDEMAR LINK GmbH &...
Medical Devices·4 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & ...
Medical Devices·5 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & ...
Medical Devices·6 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & ...
Medical Devices·8 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & ...
Medical Devices·6 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & ...
Medical Devices·5 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & C...
Medical Devices·5 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & C...
Medical Devices·9 affected·Jul 16, 2013
High RiskFDA
Brainlab Ag
BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in ...
Medical Devices·6 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & C...
Medical Devices·4 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & ...
Medical Devices·5 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 mm, WALDEMAR LINK GmbH & C...
Medical Devices·5 affected·Jul 16, 2013
High RiskFDA
Waldemar Link Gmbh & Co. Kg (corp. Hq.)
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH ...
Medical Devices·5 affected·Jul 16, 2013
High RiskFDA
Endoplus, Inc.
ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by...
Medical Devices·81 affected·Jul 15, 2013
High RiskFDA
Endoplus, Inc.
ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by...
Medical Devices·9 affected·Jul 15, 2013
High RiskFDA
Atrium Medical Corporation
Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascu...
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vas...
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypa...
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular acc...
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascul...
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular...
Medical Devices·0 affected·Jul 12, 2013
High RiskFDA
Custom Medical Specialties, Inc.
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restrict...
Medical Devices·2,610 affected·Jul 12, 2013
High RiskFDA
Atrium Medical Corporation
Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Medical Devices·0 affected·Jul 12, 2013
CriticalFDA
Depuy Orthopaedics, Inc.
LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
Medical Devices·58 affected·Jul 11, 2013
High RiskFDA
Medical Indicators, Inc.
Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial ...
Medical Devices·111,800 affected·Jul 10, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View...
Medical Devices·26 affected·Jul 10, 2013
High RiskFDA
Becton Dickinson & Co.
PrepStain Tecan US-I. For use in the screening and detection of cervical cancer.
Medical Devices·890 affected·Jul 8, 2013
High RiskFDA
Becton Dickinson & Co.
PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
Medical Devices·890 affected·Jul 8, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthca...
Medical Devices·728,256 affected·Jul 5, 2013
High RiskFDA
Radiometer America Inc
pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify...
Medical Devices·38,890 affected·Jul 5, 2013