Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging...
Medical Devices·34,650 affected·Dec 8, 2020
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging...
Medical Devices·69,275 affected·Dec 8, 2020
High RiskFDA
Oto Med Inc
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a sucti...
Medical Devices·5,092 affected·Dec 7, 2020
High RiskFDA
Carl Zeiss Meditec Ag
IOLMaster 700
Medical Devices·613 affected·Dec 7, 2020
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the...
Medical Devices·685 affected·Dec 2, 2020
High RiskFDA
Boston Scientific Corporation
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Medical Devices·7,093 affected·Dec 2, 2020
CriticalFDA
Boston Scientific Corporation
EMBLEM S-ICD Model A209
Medical Devices·1,953 affected·Dec 2, 2020
High RiskFDA
Boston Scientific Corporation
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
Medical Devices·11,296 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713
Medical Devices·31 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091
Medical Devices·197 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118
Medical Devices·589 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039
Medical Devices·170 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610
Medical Devices·54 affected·Dec 2, 2020
CriticalFDA
Boston Scientific Corporation
EMBLEM MRI S-ICD Model A219
Medical Devices·872 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061
Medical Devices·98 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884510
Medical Devices·229 affected·Dec 2, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications su...
Medical Devices·716,880 affected·Dec 2, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitori...
Medical Devices·212,093 affected·Dec 2, 2020
High RiskFDA
Biomet, Inc.
Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
Medical Devices·21 affected·Dec 1, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Medical Devices·5,602 affected·Nov 30, 2020
High RiskFDA
Biomet, Inc.
3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 11000...
Medical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including ost...
Medical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone
Medical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of sm...
Medical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures.
Medical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
Medical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, ...
Medical Devices·0 affected·Nov 25, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Medical Devices·3,044 affected·Nov 24, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·2,246 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·123 affected·Nov 23, 2020
High RiskFDA
B Braun Medical, Inc.
APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration...
Medical Devices·85 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·912 affected·Nov 23, 2020
High RiskFDA
B Braun Medical, Inc.
APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration...
Medical Devices·248 affected·Nov 23, 2020
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administ...
Medical Devices·9,353 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·278 affected·Nov 23, 2020
High RiskFDA
Roche Molecular Systems, Inc.
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Medical Devices·27 affected·Nov 23, 2020
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administ...
Medical Devices·140,006 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S...
Medical Devices·224 affected·Nov 23, 2020
High RiskFDA
Baxter Healthcare Corporation
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of...
Medical Devices·112,463 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies...
Medical Devices·3,083 affected·Nov 23, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Medical Devices·152 affected·Nov 23, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies ...
Medical Devices·2 affected·Nov 23, 2020
High RiskFDA
B Braun Medical, Inc.
APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration...
Medical Devices·16 affected·Nov 23, 2020
High RiskFDA
Zimmer Biomet, Inc.
Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument i...
Medical Devices·4,713 affected·Nov 20, 2020
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analyti...
Medical Devices·40 affected·Nov 20, 2020
High RiskFDA
Steris Corporation
Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during...
Medical Devices·23,445 affected·Nov 19, 2020
High RiskFDA
Philips North America, Llc
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for de...
Medical Devices·2,714 affected·Nov 19, 2020
High RiskFDA
Boston Scientific Corporation
IceSeed" 1.5 Cryoablation Needle
Medical Devices·152 affected·Nov 18, 2020