FDA Medical devices recall ·

MiniMed 780G Insulin Pump recall

Recall number
Z-2698-2026
Date
(initiated May 27, 2026)
Company / brand
Medtronic MiniMed, Inc.
18000 Devonshire St, Northridge, CA, United States
Category
Medical devices › Class II
Classification
Class II
Status
Ongoing
Units affected
778
Hazard tags
Software
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896

Why was it recalled?

A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA).

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

UDI-DI/GTIN: A7630006392701, 00763000521554, 00763000639273, A7630006392301, 00199150035687, A7630007325603, A7630007325601, 00763000639235, A7630007325604, 00763000384289, 00763000521530, A7630007325401, 00763000521547, A7630006392601, A7630006392201, 00763000639228, 00199150035663, 00763000639266, A7630007325404, 00199150035694, 00763000442194, A7630007325403, 00763000521523. Software version 6.62

Distribution

International distribution to the countries of Spain, Great Britain, Netherlands, Italy.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-2698-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.