CLASS II ONGOING Device recall · Reported 15 Jul 2026 · FDA Enforcement Report
MiniMed Insulin Pump recalled by Medtronic MiniMed
Medtronic MiniMed is recalling MiniMed Insulin Pump. The recall was initiated on 27 May 2026 and the FDA has classified it as Class II.
Check your package
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-2698-2026
- FDA event ID
- 99207
- Recalling firm
- Medtronic MiniMed, Northridge, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 May 2026
- FDA classified
- 8 Jul 2026
- Reported
- 15 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 27 May 2026 | Recall initiated by company | |
| 8 Jul 2026 | Classified by FDA | +42 days |
| 15 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
Where it was distributed
International distribution to the countries of Spain, Great Britain, Netherlands, Italy.
Questions about this recall
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).
Which lots are affected?
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
Where was it sold?
International distribution to the countries of Spain, Great Britain, Netherlands, Italy.
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 26 Sep 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
All 78| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | CA |
| Device | CLASS II | MiniMed Go App recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump (Mmt-1760, Mmt-1761, Mmt recalled | Medtronic MiniMed | Other | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 466| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |