Animas Vibe Insulin Infusion Pump — Class II medical device recall Z-0136-2015
Terminated recall by Animas Corporation, reported 2014-11-05. Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and cou
| Recall number | Z-0136-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Animas Corporation, West Chester, PA, United States |
| Recall initiated | 2014-06-10 |
| Classified | 2014-10-24 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2015-09-02 |
| Countries outside the US | IL |
| Quantity | 1,028 |
| Model numbers | 11220008 |
Product
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
Reason for recall
Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebrew text was omitted from the display screen.
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-0136-2015. 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.