Category

Medical Devices Recalls

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

15,654 recalls
RecallFDA
Ameditech Inc
Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU
Medical Devices·4,646 affected·Nov 16, 2015
RecallFDA
Ameditech Inc
DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D
Medical Devices·60 affected·Nov 16, 2015
RecallFDA
Ameditech Inc
ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W
Medical Devices·129 affected·Nov 16, 2015
RecallFDA
Ameditech Inc
iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142
Medical Devices·6,304 affected·Nov 16, 2015
RecallFDA
Ameditech Inc
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5.
Medical Devices·858 affected·Nov 16, 2015
RecallFDA
Ameditech Inc
DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5
Medical Devices·1,907 affected·Nov 16, 2015
RecallFDA
Ameditech Inc
ProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3
Medical Devices·200 affected·Nov 16, 2015
RecallFDA
Ameditech Inc
Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP
Medical Devices·240 affected·Nov 16, 2015
High RiskFDA
Sterilmed, Inc.
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
Medical Devices·174,960 affected·Nov 13, 2015
High RiskFDA
Corflex
CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee Brace is indicated for range of motion control at the kne...
Medical Devices·80 affected·Nov 12, 2015
High RiskFDA
Corflex
BRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087 Post-Operative Knee Brace is indicated for range of motion control...
Medical Devices·10 affected·Nov 12, 2015
High RiskFDA
Corflex
Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace is indicated for range of motion control at the ...
Medical Devices·1,406 affected·Nov 12, 2015
High RiskFDA
Corflex
ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231 Post-Operative Knee Brace is indicated for range of motion control at th...
Medical Devices·9 affected·Nov 12, 2015
High RiskFDA
Corflex
CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative Knee Brace is indicated for range of motion control at ...
Medical Devices·6 affected·Nov 12, 2015
High RiskFDA
Bestmed, Llc
Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, L...
Medical Devices·305,548 affected·Nov 12, 2015
High RiskFDA
Convatec, Inc
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are deliv...
Medical Devices·3,605,700 affected·Nov 11, 2015
High RiskFDA
Natus Neurology Dba Excel Tech., Ltd. (xltek)
Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an...
Medical Devices·56 affected·Nov 11, 2015
High RiskFDA
Shimadzu Medical Systems
Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general...
Medical Devices·297 affected·Nov 10, 2015
High RiskFDA
C.r. Bard, Inc.
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
Medical Devices·1,539 affected·Nov 10, 2015
High RiskFDA
Zimmer, Inc.
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland
Medical Devices·89 affected·Nov 10, 2015
High RiskFDA
Orthopediatrics Corp
UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabili...
Medical Devices·102 affected·Nov 10, 2015
High RiskFDA
Myco Medical Supplies Inc
Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
Medical Devices·2,401,419 affected·Nov 6, 2015
High RiskFDA
Remel Inc
Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. ...
Medical Devices·58 affected·Nov 6, 2015
High RiskFDA
Brainlab Ag
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation...
Medical Devices·48 affected·Nov 5, 2015
High RiskFDA
Brainlab Ag
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation...
Medical Devices·20 affected·Nov 5, 2015
High RiskFDA
Genesys Orthopedics Systems, Llc
Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterio...
Medical Devices·120 affected·Nov 5, 2015
High RiskFDA
Edwards Lifesciences, Llc
Thin-Flex Venous Cannula, Model Number:TF292902A
Medical Devices·8,915 affected·Nov 4, 2015
High RiskFDA
Ormco/sybronendo
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Medical Devices·161 affected·Nov 4, 2015
High RiskFDA
Biomerieux, Inc.
MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces...
Medical Devices·626 affected·Nov 3, 2015
High RiskFDA
Biomerieux, Inc.
MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfa...
Medical Devices·626 affected·Nov 3, 2015
High RiskFDA
Biomerieux, Inc.
MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: In...
Medical Devices·626 affected·Nov 3, 2015
High RiskFDA
Biomerieux, Inc.
MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: In...
Medical Devices·626 affected·Nov 3, 2015
High RiskFDA
Biomerieux, Inc.
MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces...
Medical Devices·626 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
Medical Devices·15 affected·Nov 3, 2015
High RiskFDA
Synthes (usa) Products Llc
2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and...
Medical Devices·229 affected·Nov 2, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
Medical Devices·17 affected·Oct 30, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
Medical Devices·323 affected·Oct 29, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT Computed Tomography X-ray system
Medical Devices·31 affected·Oct 29, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT Computed Tomography X-ray system
Medical Devices·51 affected·Oct 29, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray system
Medical Devices·177 affected·Oct 29, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Medical Devices·7 affected·Oct 29, 2015
High RiskFDA
Nxstage Medical, Inc.
NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
Medical Devices·133 affected·Oct 29, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core Computed Tomography X-ray system
Medical Devices·135 affected·Oct 29, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo Imaging VB36D_HF02. Radiological image processing system.
Medical Devices·3 affected·Oct 28, 2015
High RiskFDA
Masimo Corporation
rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DC...
Medical Devices·3,476 affected·Oct 28, 2015
High RiskFDA
Medtronic Perfusion Systems
Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and co...
Medical Devices·496 affected·Oct 28, 2015
High RiskFDA
Quest Medical, Inc.
Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Deliv...
Medical Devices·18,761 affected·Oct 28, 2015
High RiskFDA
Carl Zeiss Meditec Ag
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measuremen...
Medical Devices·1,882 affected·Oct 27, 2015