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
Jan 30, 2026 MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and ... Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that ... Class II Medtronic MiniMed, Inc.
Nov 13, 2025 InPen App, Model/CFN Number: MMT-8061 (Android Users) When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification St... Class II Medtronic MiniMed, Inc.
Nov 2, 2025 MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software... A software timing and processor communication issue in MiniMed" 780G software version 6.60 may tr... Class II Medtronic MiniMed, Inc.
Oct 21, 2025 CareLink Clinic, REF: MMT-7350 Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Grap... Class II Medtronic MiniMed, Inc.
Jun 16, 2025 InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design e... Class II Medtronic MiniMed, Inc.
May 7, 2025 Medtronic, Simplera Sensor, REF: MMT-5100JD1 The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and ... Class II Medtronic MiniMed, Inc.
Mar 4, 2025 InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MM... Insulin pens may have been incorrectly assembled therefore users could experience the following: ... Class II Medtronic MiniMed, Inc.
Jan 31, 2025 MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MM... All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... Class II Medtronic MiniMed, Inc.
Jan 31, 2025 MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851) All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... Class II Medtronic MiniMed, Inc.
Jan 31, 2025 MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862) All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... Class II Medtronic MiniMed, Inc.
Jan 31, 2025 MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MM... All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... Class II Medtronic MiniMed, Inc.
Jan 31, 2025 Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT... All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... Class II Medtronic MiniMed, Inc.
Jan 31, 2025 MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752) All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... Class II Medtronic MiniMed, Inc.
Jan 31, 2025 Paradigm insulin pump, REF: MMT-754 All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... Class II Medtronic MiniMed, Inc.
Jan 31, 2025 MiniMed insulin pump, REF: 620G (MMT-1750) All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... Class II Medtronic MiniMed, Inc.
Jan 31, 2025 Paradigm REF: MMT-712 and MMT-715 All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... Class II Medtronic MiniMed, Inc.
Jan 31, 2025 MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MM... All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... Class II Medtronic MiniMed, Inc.
Jan 31, 2025 MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755) All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... Class II Medtronic MiniMed, Inc.
Jan 31, 2025 MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MM... All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... Class II Medtronic MiniMed, Inc.
Jul 31, 2024 MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1... Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i... Class I Medtronic MiniMed, Inc.
Jul 31, 2024 MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582,... Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i... Class I Medtronic MiniMed, Inc.
Jul 31, 2024 MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G I... Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to i... Class I Medtronic MiniMed, Inc.
Nov 15, 2023 Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3... Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.... Class II Medtronic MiniMed, Inc.
Nov 21, 2022 Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the ... An app, part of a continuous glucose monitoring system, for use with smartphone devices may autom... Class II Medtronic MiniMed
Sep 20, 2022 Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 67... Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems... Class II Medtronic MiniMed
Sep 20, 2022 Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712... Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems... Class II Medtronic MiniMed
May 23, 2022 MiniMed 630G Insulin Pump (U.S. and Canada Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 620G Insulin Pump (O.U.S. version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 770G Insulin Pump (U.S. and O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 780G Insulin Pump (O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 670G Insulin Pump (U.S. and O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 640G Insulin Pump (O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 720G Insulin Pump (O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 740G Insulin Pump (O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
Jan 27, 2022 MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741... New or replacement insulin pumps are not pre-programmed with basal rates or other verified settin... Class II Medtronic MiniMed
Mar 15, 2021 MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PU... Due to a software design issue, under certain conditions, a software fault is detected when a lar... Class II Medtronic Minimed
Mar 15, 2021 MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ ... Due to a software design issue, under certain conditions, a software fault is detected when a lar... Class II Medtronic Minimed
Nov 21, 2019 Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-... There have been reported incidents of a loose reservoir that can no longer be locked into the pum... Class I Medtronic Inc.
Nov 21, 2019 Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MM... There have been reported incidents of a loose reservoir that can no longer be locked into the pum... Class I Medtronic Inc.
Nov 21, 2019 Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT... There have been reported incidents of a loose reservoir that can no longer be locked into the pum... Class I Medtronic Inc.
Nov 21, 2019 Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715... There have been reported incidents of a loose reservoir that can no longer be locked into the pum... Class I Medtronic 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

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.