t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM — Class II medical device recall Z-1258-2022
Ongoing recall by Tandem Diabetes Care Inc, reported 2022-06-22. Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life doe
| Recall number | Z-1258-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tandem Diabetes Care Inc, San Diego, CA, United States |
| Recall initiated | 2020-09-10 |
| Classified | 2022-06-10 |
| Reported by FDA | 2022-06-22 |
| Countries outside the US | AU |
| Quantity | 5,206 |
Product
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Reason for recall
Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to 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-1258-2022. 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.