Animas Vibe Insulin Infusion Pump and System — Class II medical device recall Z-0137-2015
Terminated recall by Animas Corporation, reported 2014-11-05. Animas determined that keypad wear over time was contributing to an increased complaint rate associated with d
| Recall number | Z-0137-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Animas Corporation, West Chester, PA, United States |
| Recall initiated | 2012-10-25 |
| Classified | 2014-10-24 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2015-06-29 |
| Countries outside the US | FR, GB, IT, SE |
| Quantity | 1,938 |
| Model numbers | 100510-02, 100510-03, 100510-04, 100510-53, 100510-56, 100510-57, 100510-63, 100510-67, 100511-02, 100511-03, 100511-04, 100511-53, 100511-56, 100511-57, 100511-63, 100512-02, 100512-03, 100512-04, 100512-53, 100512-56, 100512-57, 100512-63, 100514-02, 100514-03, 100514-04 and 40 more |
Product
Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
Reason for recall
Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump and System. Animas has implemented an improvement to the keypad related to the material used to reduce susceptibility to damage and increase durability.
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-0137-2015. 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.