Autoject E1 Fixed needle device — Class II medical device recall Z-1366-2015
Terminated recall by Owen Mumford USA, Inc., reported 2015-04-08, distributed nationwide. The syringe carrier is missing components: a damper and spring.
| Recall number | Z-1366-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Owen Mumford USA, Inc., Marietta, GA, United States |
| Recall initiated | 2014-11-24 |
| Classified | 2015-04-02 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2017-07-31 |
| Distributed | Nationwide (US) |
| Quantity | 3,100 |
| UPC / GTIN / UDI-DI | 00384701310010 |
| Lot numbers | 5LW |
| Model numbers | AJ1310 |
Product
Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.
Reason for recall
The syringe carrier is missing components: a damper and spring.
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-1366-2015. 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.