FDA Device recall Z-0137-2015
Animas Vibe Insulin Infusion Pump and System
- FDA Device
- Class II
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class II recall of Animas Vibe Insulin Infusion Pump and System by Animas, citing 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 h….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0137-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-25 |
| Published | 2014-11-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Animas |
| Distribution | n/a |
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
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.
Identifiers
| code_info | Part Numbers 101200-57 100512-57 100510-02 100510-03 100510-04 100510-53 100510-56 100510-57 100510-63 10…Part Numbers 101200-57 100512-57 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 100512-02 100512-03 100512-04 100512-53 100512-56 100512-57 100512-63 100514-02 100514-03 100514-04 100514-53 100514-56 100514-57 100514-63 100515-02 100515-03 100515-04 100515-53 100515-56 100515-57 100515-63 101200-02 101002-03 101002-53 101002-56 101002-57 101002-63 101201-02 101201-03 101201-53 101210-56 101201-57 101201-63 101202-02 101202-03 101202-04 101202-53 101202-57 101202-63 101204-03 101204-04 101204-53 101204-57 101204-63 101205-03 101205-53 101205-56 101205-57 101205-63 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0137-2015%22
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