Recall Z-2980-2026
Medtronic MiniMed, Inc. · initiated July 13, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
Codes / lots: Model/UDI-DI/Serial Numbers: MMT-1711/00763000404550/NG2660048H, NG2663343H, NG3015306H; MMT-1712/00763000404567/NG2628486H, NG2758213H, NG2999651H, NG3349198H, NG3351719H, NG2678842H, NG2831821H, NG2831546H, NG2932027H, NG3049657H, NG3033094H, NG2831538H, NG3738739H
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.
FDA-determined cause: Process design
Action taken
On 7/13/2026, field safety notices were sent to customers asking them to do the following: 1) Stop using the loaner pump and contact the firm to arrange for loaner pump return. 2) Contact your Healthcare Professional (HCP) to ensure you have access to backup insulin therapy supplies or alternative plans, which may include short- and long-acting insulins, syringes, with dosage instructions from your HCP. 3) Complete and return the customer acknowledgement form. Questions can be directed to the firm's Tech Support: 1-800-646-4633
Details
- Recall number
- Z-2980-2026
- Initiated
- July 13, 2026
- Posted by FDA
- August 18, 2026
- Product code
- QFG – Alternate Controller Enabled Insulin Infusion Pump
- Quantity
- 16
- Distribution
- International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.
- Recalling firm
- Medtronic MiniMed, Inc., Northridge, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2981-2026 Class II | MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump… | 07/13/2026Open, Classified |
| Z-2982-2026 Class II | MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLWLoaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump… | 07/13/2026Open, Classified |