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Browse Device Recalls

1,680 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,680 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 1,680 FDA device recalls.

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DateProductReasonClassFirm
Nov 14, 2019 Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351 Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in t... Class II Medtronic Perfusion Systems
Nov 13, 2019 Lamicel 20PK 3MM INTL Cervical dilator Routine sterilization dose does not meet the required Sterility Assurance Level. Class II Medtronic Xomed, Inc.
Nov 13, 2019 Lamicel 20PK 5MM INTL Routine sterilization dose does not meet the required Sterility Assurance Level. Class II Medtronic Xomed, Inc.
Nov 13, 2019 Lamicel 10PK 10MM INTL Routine sterilization dose does not meet the required Sterility Assurance Level. Class II Medtronic Xomed, Inc.
Oct 30, 2019 Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth sto... Class II Medtronic Navigation, Inc.
Oct 30, 2019 Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108 The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth sto... Class II Medtronic Navigation, Inc.
Oct 30, 2019 Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517 The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth sto... Class II Medtronic Navigation, Inc.
Oct 11, 2019 Synchromed II programmable pump, Model numbers 8637-20 and 8637-40 There is a potential for the presence of a foreign particle inside the pump motor assembly which ... Class I Medtronic Neuromodulation
Oct 3, 2019 Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer There is a potential for Medtronic programmer and remote monitoring software applications to disp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 3, 2019 Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Man... There is a potential for Medtronic programmer and remote monitoring software applications to disp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 3, 2019 Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer There is a potential for Medtronic programmer and remote monitoring software applications to disp... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Sep 3, 2019 Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP150... Medtronic has determined that some catheters have a slightly higher diameter stylette causing rem... Class II Medtronic Vascular Galway DBA Medtronic Ireland
Sep 3, 2019 Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC150... Medtronic has determined that some catheters have a slightly higher diameter stylette causing rem... Class II Medtronic Vascular Galway DBA Medtronic Ireland
Aug 28, 2019 NavLock Tracker *** Rx Only Product was incorrectly assembled which could affect navigation accuracy of the device. Class II Medtronic Navigation, Inc.
Aug 9, 2019 Medtronic Nexframe Stereotactic System and StealthStation Cranial software ve... Entry point and lead placement inaccuracies during deep brain stimulation lead implantation proce... Class I Medtronic Navigation, Inc.
Aug 6, 2019 Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1V... Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Ca... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Aug 6, 2019 Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker. Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Ca... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jul 8, 2019 Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: ... The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VC... Class II Medtronic Navigation, Inc.
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-523 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT... The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-722 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 MiniMed Paradigm Model 511 Insulin Pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 MiniMed Paradigm Insulin pump, model number MMT-712 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 MiniMed Paradigm 512 Insulin pump The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-522 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 MiniMed Insulin Pump, model # MMT-508 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
Jun 27, 2019 Medtronic MiniMed Paradigm Insulin pump, model number MMT-723 The action is being initiated due to potential cybersecurity vulnerabilities related to a series ... Class II Medtronic MiniMed
May 21, 2019 Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replaceme... Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... Class II Medtronic Inc
May 21, 2019 Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replace... Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... Class II Medtronic Inc
May 21, 2019 Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of ... Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... Class II Medtronic Inc
May 21, 2019 Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of ... Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... Class II Medtronic Inc
May 21, 2019 Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replaceme... Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... Class II Medtronic Inc
May 20, 2019 Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used... Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad o... Class II Medtronic Inc.
May 15, 2019 InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) ... There is a potential for an unexpected increase in stimulation during InterStim programming with ... Class II Medtronic Neuromodulation
May 1, 2019 Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XX... The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the syst... Class II Medtronic Navigation, Inc.-Littleton
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for ... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB SH, 90CM, 070", REF SA6RCBSHD. f... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB SH, .070", REF SA6LCBSH. for card... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F MP ST, .070", REF SA6MPST. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070", REF SA6AR10SH. f... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5, .070", REF SA6JL45. for cardio... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. for c... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for... There is a potential for extensive loss of primary segment material exposing underlying stainless... Class I Medtronic Vascular

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.