Browse Device Recalls

1,646 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,646 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 1,646 FDA device recalls in MN.

Clear
DateProductReasonClassFirm
Feb 3, 2021 Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR,... A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Feb 3, 2021 Implantable cardioverter defibrillators (ICD) with cardiac resynchronization ... A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 22, 2021 ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular U... Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section... Class I Acist Medical Systems
Jan 20, 2021 Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR imm... R&D Systems, Inc. received two complaints that the standard signal was low and controls were not ... Class II R & D Systems, Inc.
Jan 18, 2021 Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend... Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless Fle... Class II Smiths Medical ASD Inc.
Jan 11, 2021 Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product... Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. ... Class II Ecolab Inc
Dec 21, 2020 Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use... Shipping box may contain wrong model. Class II Smiths Medical ASD Inc.
Dec 16, 2020 KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO ... Contamination with S. epidermidis Class II Microbiologics Inc
Dec 16, 2020 KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affecte... The expiration date on the label of one component (negative control 0243U) in the set lot is inco... Class III Microbiologics Inc
Dec 15, 2020 ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate g... Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that d... Class II Boston Scientific Corporation
Dec 15, 2020 PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60P... A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incor... Class II Smiths Medical ASD Inc.
Dec 8, 2020 smiths medical portex Loss of Resistance Device, REF 100/398/000 The labeling was missing information on sterilization and prohibition of reuse. Class II Smiths Medical ASD Inc.
Dec 2, 2020 EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System;... Accelerated battery depletion may result in a need for device replacement earlier than expected. Class II Boston Scientific Corporation
Dec 2, 2020 EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Mod... Accelerated battery depletion may result in a need for device replacement earlier than expected. Class II Boston Scientific Corporation
Dec 2, 2020 EMBLEM MRI S-ICD Model A219 Electrical overstress may lead to device malfunction. Class I Boston Scientific Corporation
Dec 2, 2020 EMBLEM S-ICD Model A209 Electrical overstress may lead to device malfunction. Class I Boston Scientific Corporation
Nov 23, 2020 LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immun... Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient s... Class II Diasorin Inc.
Nov 19, 2020 Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC ... A software anomaly in the A620 Patient Programmer application was identified that results in fail... Class II Medtronic Neuromodulation
Nov 18, 2020 IceSphere" 1.5 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿ Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IcePearl" 2.1 CX Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 MRI 90¿ Cryoablation Needle¿ Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" i-Thaw" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSeed" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" He-Thaw Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceFORCE" 2.1 CX L 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSphere" 1.5 Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceFORCE" 2.1 CX Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" i-Thaw" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 PLUS Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSphere" 1.5 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 Three IceFORCE" 2.1 CX Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceFORCE" 2.1 CX Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 MRI Cryoablation Needle¿ Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IcePearl" 2.1 CX L 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 Three IcePearl" 2.1 CX Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSeed" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceEDGE" 2.4¿ 90p¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 Five IceRod" i-Thaw" Prostate Cryoablation Kit Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 PLUS 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceFORCE" 2.1 CX 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSphere" 1.5 S 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSphere" 1.5 Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSphere" 1.5 CX 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSeed" 1.5 MRI Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceSeed" 1.5 90¿ Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation
Nov 18, 2020 IceRod" 1.5 i-Thaw" Cryoablation Needle Complaint trend regarding needle shaft gas leaks. Class II Boston Scientific Corporation

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.