Class II — Owen Mumford USA, Inc.
| Recalling firm | OWEN MUMFORD LTD. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 225 units |
| Distribution | Nationwide Distribution including FL, IL, NV, NJ, OH, and TN. |
| Initiated | 2014-12-11 |
| Classified | 2015-07-15 |
| Terminated | 2017-07-11 |
| Recall number | Z-2082-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Owen Mumford USA, Inc. (Z-2082-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70783/
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