CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report

MiniMed Flex Insulin Pump recalled by Medtronic MiniMed

Medtronic MiniMed is recalling MiniMed Flex Insulin Pump, distributed nationwide in the US. The recall was initiated on 20 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMMT-8072 Lot Code: Serial numbers: FB00015839, FB00016511, FB00014455, FB00011553, FB00015700, FB00011357, FB00019307, FB00014766, FB00014822, FB00015828, FB00018580, FB00010465, FB00014472, FB00015793, FB00015794, FB00015796, FB00015799, FB00015801, FB00015977, FB00017271. UDI-DI/GTIN: 00763000848156 Note: Initially 25 pumps were identified as put into service, however 2 were shipped to Marketing Team Members and recovered. 3 Pumps were returned through complaint process. Final total of pumps available in the field is 20. MMT-8062 Lot Code: Serial numbers: FB00011770, FB00015162, FB00016429, FB00014760, FB00015797 UDI-DI/GTIN: 00763000848149 (Serial Numbers: FB00017271, FB00011770, FB00015162, FB00016429, FB00014760 were returned via complaint process or shipped to Marketing Team Members).

Quantity recalled25

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0088-2027
FDA event ID: 99818
Recalling firm: Medtronic MiniMed, Northridge, CA
Classification: Class II
Status: Ongoing
Recall initiated: 20 Aug 2026
FDA classified: 5 Oct 2026
Reported: 14 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Labeling Errors
Device type: Insulin Pumps & Glucose Monitors

Timeline

20 Aug 2026	Recall initiated by company
5 Oct 2026	Classified by FDA	+46 days
14 Oct 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed pumps released to users potentially have one or more of the following issues: inoperable pump at setup, lack of protection for moisture exposure, slow battery charging, disconnection issues with other system components (i.e., continuous glucose monitoring sensor or MiniMed mobile app), reduced ability to detect occlusion events, compromised audio for pump alarms/alerts, and/or inaccurate insulin delivery.

Product as listed by the FDA

Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controller enabled (ACE) pump intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. It can reliably and securely communicate with compatible digitally connected devices, including an integrated continuous glucose monitor (iCGM), interoperable Medtronic continuous glucose monitor (CGM), and interoperable automated glycemic controller (iAGC). The pump is intended to be used in conjunction with compatible, digitally connected medical devices for the purpose of drug delivery. The primary user interface and primary display for the MiniMed Flex pump is the MiniMed app, also the user interface for the compatible MiniMed iAGCs, which runs on a compatible iOS or Android device.

Where it was distributed

U.S. Nationwide distribution in the states of AR, AZ, CO, FL, KS, KY, LA, MI, MN, NJ, NY, OH, PA, SD, TN, TX, and WV.

Nationwide Arkansas Arizona Colorado Florida Kansas Kentucky Louisiana Michigan Minnesota New Jersey New York Ohio Pennsylvania South Dakota Tennessee Texas West Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

MMT-8072 Lot Code: Serial numbers: FB00015839, FB00016511, FB00014455, FB00011553, FB00015700, FB00011357, FB00019307, FB00014766, FB00014822, FB00015828, FB00018580, FB00010465, FB00014472, FB00015793, FB00015794, FB00015796, FB00015799, FB00015801, FB00015977, FB00017271. UDI-DI/GTIN: 00763000848156 Note: Initially 25 pumps were identified as put into service, however 2 were shipped to Marketing Team Members and recovered. 3 Pumps were returned through complaint process. Final total of pumps available in the field is 20. MMT-8062 Lot Code: Serial numbers: FB00011770, FB00015162, FB00016429, FB00014760, FB00015797 UDI-DI/GTIN: 00763000848149 (Serial Numbers: FB00017271, FB00011770, FB00015162, FB00016429, FB00014760 were returned via complaint process or shipped to Marketing Team Members).

Where was it sold?

U.S. Nationwide distribution in the states of AR, AZ, CO, FL, KS, KY, LA, MI, MN, NJ, NY, OH, PA, SD, TN, TX, and WV.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Medtronic MiniMed

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Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
29 Jul 2026Device	CLASS II	MiniMed Go App recalled by Medtronic MiniMed	Medtronic MiniMed	Other	Nationwide
15 Jul 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Device Malfunction	CA

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