Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Zimmer Biomet, Inc.
NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202267012 0202267014 0202267016 0202267018
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 32855331115 32855331161 32855331163 32855331165
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Zimmer Biomet, Inc.
CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202
Medical Devices·5,459,583 affected·Oct 10, 2019
High RiskFDA
Medivators, Inc.
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pu...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Nextremity Solutions
Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating S...
Medical Devices·49 affected·Oct 9, 2019
High RiskFDA
Stryker Sustainability Solutions
Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet C...
Medical Devices·90 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scien...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Draegar Medical Systems, Inc.
Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862,...
Medical Devices·12,204 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. Tubing for Olympus ...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Medivators, Inc.
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. Tubing for O...
Medical Devices·53,790 affected·Oct 9, 2019
High RiskFDA
Baylis Medical Company Inc.
TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45...
Medical Devices·59,067 affected·Oct 7, 2019
High RiskFDA
Beckman Coulter, Inc.
UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows...
Medical Devices·1,056 affected·Oct 7, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definiti...
Medical Devices·305 affected·Oct 7, 2019
High RiskFDA
Nova Ortho-med Inc
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
Medical Devices·10,898 affected·Oct 7, 2019
High RiskFDA
Baylis Medical Company Inc.
NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, ...
Medical Devices·59,067 affected·Oct 7, 2019
High RiskFDA
Smith & Nephew, Inc.
LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN InterTAN nails are indicated for fractures of the femur includ...
Medical Devices·116 affected·Oct 7, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·2,760 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·986 affected·Oct 4, 2019
High RiskFDA
Icu Medical, Inc.
REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI: (01)00887709028074
Medical Devices·4,800 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·1,014 affected·Oct 4, 2019
High RiskFDA
Icu Medical, Inc.
REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00...
Medical Devices·650 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·336 affected·Oct 4, 2019
High RiskFDA
Icu Medical, Inc.
REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Sterile R, UDI: (01)00...
Medical Devices·14,000 affected·Oct 4, 2019
CriticalFDA
Ventana Medical Systems Inc
Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP)...
Medical Devices·461 affected·Oct 4, 2019
High RiskFDA
Icu Medical, Inc.
REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext...
Medical Devices·25 affected·Oct 4, 2019
High RiskFDA
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
Medical Devices·988 affected·Oct 4, 2019
CriticalFDA
Ethicon Endo-surgery Inc
ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
Medical Devices·849 affected·Oct 3, 2019
CriticalFDA
Ethicon Endo-surgery Inc
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
Medical Devices·255 affected·Oct 3, 2019
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
Medical Devices·6,713 affected·Oct 3, 2019
High RiskFDA
Datascope Corp.
Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number ...
Medical Devices·7 affected·Oct 3, 2019
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
Medical Devices·874 affected·Oct 3, 2019
CriticalFDA
Ethicon Endo-surgery Inc
ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
Medical Devices·2,112 affected·Oct 3, 2019
High RiskFDA
Medicrea International
Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
Medical Devices·14 affected·Oct 2, 2019
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The ...
Medical Devices·13 affected·Oct 1, 2019
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The mon...
Medical Devices·9 affected·Oct 1, 2019
High RiskFDA
Monarch Medical Technologies
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Medical Devices·6 affected·Oct 1, 2019
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The moni...
Medical Devices·14 affected·Oct 1, 2019
High RiskFDA
Arthrex, Inc.
Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is i...
Medical Devices·20 affected·Oct 1, 2019
CriticalFDA
Ge Healthcare, Llc
Airway Gas Option N-CAiO
Medical Devices·12 affected·Sep 27, 2019
High RiskFDA
Life Technologies Holdings Pte Ltd
Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARU...
Medical Devices·400 affected·Sep 26, 2019
RecallFDA
Theralase Inc.
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
Medical Devices·41 affected·Sep 26, 2019
RecallFDA
Theralase Inc.
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
Medical Devices·76 affected·Sep 26, 2019
RecallFDA
Theralase Inc.
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Medical Devices·202 affected·Sep 26, 2019
RecallFDA
Theralase Inc.
TLC-2000 Therapeutic Medical Laser System
Medical Devices·18 affected·Sep 26, 2019
RecallFDA
Theralase Inc.
TLC-2000 Therapeutic Medical Laser System
Medical Devices·92 affected·Sep 26, 2019