Category

Medical Devices Recalls

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

15,654 recalls
RecallFDA
Philips Medical Systems (cleveland) Inc
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cro...
Medical Devices·93 affected·Aug 28, 2012
High RiskFDA
Zimmer, Inc.
Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip...
Medical Devices·1 affected·Aug 27, 2012
High RiskFDA
Spacelabs Healthcare, Llc
Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the...
Medical Devices·527 affected·Aug 27, 2012
High RiskFDA
Iradimed Corporation
The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion adm...
Medical Devices·719 affected·Aug 24, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomograph...
Medical Devices·328 affected·Aug 24, 2012
High RiskFDA
Volcano Corporation
Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607...
Medical Devices·1,020 affected·Aug 24, 2012
High RiskFDA
Biomet, Inc.
Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and os...
Medical Devices·268 affected·Aug 23, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into...
Medical Devices·12 affected·Aug 22, 2012
High RiskFDA
Covidien Lp
Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. Single Use Loading Unit (SULU) t...
Medical Devices·135,712 affected·Aug 21, 2012
High RiskFDA
Covidien Lp
Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A. Single Use Loading Unit (SULU) t...
Medical Devices·268,022 affected·Aug 21, 2012
High RiskFDA
Covidien Lp
Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissu...
Medical Devices·433,528 affected·Aug 21, 2012
High RiskFDA
Covidien Lp
Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. Single Use Loading Unit (SULU) t...
Medical Devices·94,301 affected·Aug 21, 2012
High RiskFDA
Remel Inc
Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com (Both Remel &am...
Medical Devices·30 affected·Aug 21, 2012
High RiskFDA
Covidien Lp
Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. Single Use Loading Unit (SULU) t...
Medical Devices·104,355 affected·Aug 21, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland,...
Medical Devices·112 affected·Aug 21, 2012
High RiskFDA
Covidien Lp
Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue ...
Medical Devices·22,218 affected·Aug 21, 2012
High RiskFDA
Elekta, Inc.
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension...
Medical Devices·52 affected·Aug 21, 2012
High RiskFDA
Remel Inc
Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The re...
Medical Devices·23 affected·Aug 21, 2012
High RiskFDA
Vital Signs Colorado Inc.
Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
Medical Devices·243,685 affected·Aug 17, 2012
RecallFDA
Amsino Medical Usa
0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nas...
Medical Devices·0 affected·Aug 15, 2012
High RiskFDA
Philips Healthcare Inc.
Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. Th...
Medical Devices·2,314 affected·Aug 15, 2012
High RiskFDA
Sorin Group Usa, Inc.
Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
Medical Devices·1,125 affected·Aug 15, 2012
High RiskFDA
Lansinoh Laboratories Inc
THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeu...
Medical Devices·51,472 affected·Aug 14, 2012
High RiskFDA
Neomend Inc
Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated ...
Medical Devices·95 affected·Aug 13, 2012
High RiskFDA
Capsule Tech Inc.
Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docki...
Medical Devices·12,448 affected·Aug 10, 2012
High RiskFDA
Steris Corporation
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization pro...
Medical Devices·64 affected·Aug 10, 2012
High RiskFDA
Cefla Dental Group
MyRay RXDC dental unit x-ray unit
Medical Devices·173 affected·Aug 10, 2012
High RiskFDA
Omni Life Science
Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a pr...
Medical Devices·182 affected·Aug 9, 2012
High RiskFDA
Omni Life Science
Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a pr...
Medical Devices·270 affected·Aug 9, 2012
High RiskFDA
Stryker Spine
SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 The Xia 3/Mantis ...
Medical Devices·28 affected·Aug 9, 2012
High RiskFDA
Omni Life Science
Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a pr...
Medical Devices·286 affected·Aug 9, 2012
High RiskFDA
Stryker Spine
Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.3...
Medical Devices·19 affected·Aug 9, 2012
High RiskFDA
Agfa Corp.
AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image ...
Medical Devices·535 affected·Aug 9, 2012
High RiskFDA
Parks Medical Electronics, Inc
Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices a...
Medical Devices·349 affected·Aug 8, 2012
High RiskFDA
Zoll Circulation, Inc.
AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Ches...
Medical Devices·3,881 affected·Aug 8, 2012
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to trea...
Medical Devices·100 affected·Aug 6, 2012
High RiskFDA
Thyssenkrupp Access Corp
ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobility impaired person in a fold-down seat up an...
Medical Devices·5,413 affected·Aug 6, 2012
High RiskFDA
Orthofix, Inc
Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the ...
Medical Devices·1,224 affected·Aug 6, 2012
High RiskFDA
Covidien Llc
HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex E...
Medical Devices·617 affected·Aug 3, 2012
High RiskFDA
Medical Specialties Distributors, Inc.
Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialtie...
Medical Devices·472 affected·Aug 3, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and di...
Medical Devices·126 affected·Aug 3, 2012
RecallFDA
Phadia Us Inc
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Medical Devices·837 affected·Aug 2, 2012
High RiskFDA
Hospira, Inc.
Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a c...
Medical Devices·0 affected·Aug 2, 2012
High RiskFDA
Imaging Sciences International, Llc
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Medical Devices·366 affected·Jul 30, 2012
High RiskFDA
Elekta, Inc.
Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas ...
Medical Devices·2 affected·Jul 27, 2012
High RiskFDA
Biomet U.k., Ltd.
Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femu...
Medical Devices·119 affected·Jul 27, 2012
High RiskFDA
Agfa Corp.
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sh...
Medical Devices·280 affected·Jul 27, 2012
High RiskFDA
St. Jude Medical
Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs...
Medical Devices·34,617 affected·Jul 26, 2012