Autopen Classic Automatic insulin delivery pen — Class II medical device recall Z-2082-2015
Terminated recall by Owen Mumford USA, Inc., reported 2015-07-22, distributed nationwide. The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a r
| Recall number | Z-2082-2015 |
|---|---|
| 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 | 2014-12-11 |
| Classified | 2015-07-15 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2017-07-11 |
| Distributed | Nationwide (US) |
| Quantity | 225 units |
| UPC / GTIN / UDI-DI | 00384703800014 |
| NDC | 08470-3800-01 |
| Lot numbers | 7JH |
Product
Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
Reason for recall
The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection.
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-2082-2015. 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.