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Browse Device Recalls

84 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 84 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 84 FDA device recalls.

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DateProductReasonClassFirm
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
Oct 3, 2018 Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 60258... Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expe... Class II Medtronic Inc.
Apr 24, 2018 Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554,... The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.T... Class II Medtronic Inc.
Sep 10, 2017 Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398... Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class II Medtronic Inc.
Sep 10, 2017 Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T... Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class II Medtronic Inc.
Sep 10, 2017 Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 36... Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class II Medtronic Inc.
Sep 10, 2017 Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 8... Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class II Medtronic Inc.
Sep 10, 2017 Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281) Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. Class II Medtronic Inc.
May 8, 2017 MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512,... Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755. Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782,... Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
May 8, 2017 MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550,... Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar... Class II Medtronic Inc.
Dec 23, 2016 BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed ... Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also n... Class II Becton Dickinson & Company
Aug 5, 2016 CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the... Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp ... Class II Medtronic Inc.
Feb 19, 2016 CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospec... Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink i... Class II Medtronic MiniMed Inc.
Sep 25, 2015 MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed... The pump drive motors may experience a malfunction which would result in a pump error message ala... Class II Medtronic MiniMed Inc.
Sep 25, 2015 MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 T... The pump drive motors may experience a malfunction which would result in a pump error message ala... Class II Medtronic MiniMed Inc.
Jul 22, 2015 Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or p... Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System becaus... Class II Medtronic MiniMed Inc.
Jun 19, 2015 MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), ... Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain ... Class II Medtronic MiniMed Inc.
Nov 10, 2014 CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software... The firm is informing customers of a software error that might result in an inaccurate display of... Class III Medtronic MiniMed Inc.
Nov 4, 2014 Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Si... Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T... Class II Medtronic MiniMed Inc.
Jul 21, 2014 Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Us... Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue t... Class II Medtronic MiniMed Inc.
Jun 16, 2014 Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a ... Class II Medtronic MiniMed Inc.
Apr 4, 2014 Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtr... Some refill kits in the affected lots may contain an extension tubing set that is occluded and he... Class II Medtronic Neuromodulation
Mar 13, 2014 Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-5... Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have re... Class II Medtronic MiniMed Inc.
Jul 3, 2013 Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332... Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and... Class II Medtronic MiniMed
Jun 7, 2013 Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion set... Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMe... Class I Medtronic MiniMed
Mar 22, 2013 Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, ... Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap m... Class II Medtronic MiniMed

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.