Browse Device Recalls

1,708 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,708 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 1,708 FDA device recalls.

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DateProductReasonClassFirm
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
Mar 15, 2019 SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO, 100CM, 070", REF SA6NOTO. 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 RBU4.0 SH, .070", REF SA6RBU40SH. 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, RBU3.5, 100CM, 070", REF SA6RBU35. 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 ERAD LEFT SH, .070", REF SA6ERADLSH. ... 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, HSI, 100CM, 070", REF SA6HSI. for ca... 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 SAL3.0, .070", REF SA6SAL30. 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, AR2.0 SH, 100CM.070", REF SA6AR20SH. ... 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 JL4.0, .070", REF SA6JL40. 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 ALR1-2, .070", REF SA6ALR12. 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 AL2.5, .070:, REF SA6AL25. 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, AL.75 110CM.070", REF SA6AL75A. 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 M RESS, .070", REF SA6MRESS. 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 MP1 SH, .070", REF SA6MP1SH. 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 JR3.5, .070", REF SA6JR35. 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 SL3.5, .070", REF SA6SL35. 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 RCB SH, .070", REF SA6RCBSH. 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, JR4.0, 55CM, 070", REF SA6JR40K. 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 CHAMP1.0, .070", REF SA6CHAMP10. 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 EBU3.75 SH, .070", REF SA6EBU375SH. 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 HSII, .070", REF SA6HSII. for cardiov... 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 SCR4.0 SH, .070", REF SA6SCR40SH. 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 JL6.0, .070", REF SA6JL60. for cardi... 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.