Browse Device Recalls

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,729 FDA device recalls in 2014.

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DateProductReasonClassFirm
Apr 25, 2014 RayStation software version 4.0.3.4 RayStation is a software system design... This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT h... Class II RAYSEARCH LABORATORIES AB
Apr 25, 2014 VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory s... The keyboard and monitor may not be properly secured to the monitor arm. Class III Siemens Medical Solutions Diagnostics
Apr 25, 2014 Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usag... The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a ... Class II Hitachi Medical Systems America Inc
Apr 25, 2014 BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (Bio... Serum albumin component monomer failed to meet internally established end of shelf-life specifica... Class II CryoLife, Inc.
Apr 25, 2014 Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and... 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disco... Class II Fresenius Medical Care Holdings, Inc.
Apr 25, 2014 Revision K Actuator Test Boards sold as replacement parts for use with Frese... 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disco... Class II Fresenius Medical Care Holdings, Inc.
Apr 24, 2014 Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 ... Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Apr 24, 2014 Bard¿ Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450... Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Apr 24, 2014 DISP 9730951 STRL SPHERE, 5PK INSERT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indica... Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Apr 24, 2014 HLD Systems Model 610 Washer/High Level Disinfector. Maximum weight of t... Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a... Class II Cenorin, LLC
Apr 24, 2014 PACK 9731975 TUMOR RESECTION AXIEM CR Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 BAG 9732315 MOUSE STERILE 15 PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PIN, 9733235, 100MM, STERILE, PERC REF Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 ... Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Apr 24, 2014 PATIENT TRACKER 9733534XOM ENT 1PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 In... Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Apr 24, 2014 BIOPSY NEEDLE KIT, 9733068, PASSIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 INST 9731132 KIT CR REF FRAME DRIVER 5PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Ind... Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Apr 24, 2014 TUMOR RESECTION KIT 9733608 SKULL MOUNT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 I... Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Apr 24, 2014 PIN, 9733236, 150MM, STERILE, PERC REF Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 In... Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Apr 24, 2014 TRAJ GUIDE KIT, 9733066, BIOPSY, INT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Pro... Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 1... Class II Mar Cor Purification
Apr 24, 2014 DISP 9730950 STRL SPHERE, 1 PK INSERT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 INSTRUMENT TRACKER 9733533XOM ENT 1PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 SHUNT KIT 9733605 NON-INVASIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TUMOR RESECTION KIT 9733607 NON-INVASIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for us... Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Apr 24, 2014 Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 I... Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Apr 24, 2014 SPHERES 8801075 5/TRAY 12PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 Baxter Amia Automated PD systems are used in the treatment of adult renal fai... System error 01779 is produced when the battery cannot be charged due to specific voltage differe... Class II Baxter Healthcare Corp.
Apr 24, 2014 BIT 9733516 2.9mm DRILL STERILE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TRAJ GUIDE KIT, 9733065, BIOPSY, EXT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in t... Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Apr 24, 2014 Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indi... Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Apr 24, 2014 SPHERES 8801071 1/TRAY 12PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 ... Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Apr 24, 2014 MOUSE 9732721 STERILE O-ARM 10PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 ENT PRGM 9734636 ADD FUSION NAV AxiEM Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 I... Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Apr 24, 2014 Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use... Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Apr 24, 2014 KIT, 9731427, THORACIC TACTILE PROBES Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TUMOR RES. PACK 9733553 AxiEM S.M. Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 DRAPE 9732722 TUBE STERILE O-ARM 20PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 UPGRD PRGM 9734638 ADD AxiEM NAVIGATION Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic r... Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may ha... Class II Siemens Medical Solutions USA, Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.