Recall Z-2980-2026— Medtronic MiniMed, Inc.

Name: FDA recall Z-2980-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-13

Class II · Ongoing

Class II FDA medical device recall by Medtronic MiniMed, Inc., initiated 2026-07-13. It names one FDA 510(k) clearance: K251032. Product: MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;. Reason: Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis..

Recalling firm: Medtronic MiniMed, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-07-13
Firm location: Northridge, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K251032 — MiniMed 780G insulin pumpMedtronic Minimed, Inc.·cleared 2025-07-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;

Reason for recall

Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

Data sourced from openFDA. This site is unofficial and independent of the FDA.