Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps… — Class I medical device recall Z-0427-2026
Ongoing recall by Tandem Diabetes Care, Inc., reported 2025-11-12, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. P
| Recall number | Z-0427-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tandem Diabetes Care, Inc., San Diego, CA, United States |
| Recall initiated | 2025-10-06 |
| Classified | 2025-11-05 |
| Reported by FDA | 2025-11-12 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY |
| Quantity | 17,745 |
| Reason classes | device malfunction, software |
| UPC / GTIN / UDI-DI | 00389152075013, 00389152271910, 00389152350110, 00389152365510, 00389152365619, 00389152370019, 00389152408170 |
Product
Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). Pump, Tandem Mobi, Control-IQ/1010750, Pump, Tandem Mobi, Control-IQ, Replacement/1012719, Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501, Pump, Tandem Mobi, Control-IQ 7.7/1013655, Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656, Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700, Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081
Reason for recall
Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0427-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.