FDA Medical Device Recalls (openFDA)
Owen Mumford USA, Inc.: 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.
- Recall number
- Z-2082-2015
- Recalling firm
- Owen Mumford USA, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-12-11
- Posted
- 2015-07-15
- Terminated
- 2017-07-11
- 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.
- Root cause
- Process control
- Action
- Owen Mumford, Inc. sent an Urgent Medical Device Recall Notification letter dated December 19, 2014, to all affected customers via Fed Ex. The letter instructed customers to check their shelves for the product and specific lot number. The customer was instructed to contact Customer Service to obtain an RMA and a pre-paid, pre-addressed label for return of the devices. A form was included for the documentation of the inspection of their inventory, whether any are in stock and will be returned, and if they will provide a customer list of how they sold any devices to or that they will notify their customers of the issue with the product. They were instructed to fill it out and fax back to 770-977-2866. Customers with questions were instructed to contact Customer Service Department at 1-800-421-6936. For questions regarding this recall call 770-977-2226, ext 13.
- Quantity
- 225 units
- Distribution
- Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
- Lot, serial or model codes
- Lot 7JH, UPC Code 384703800014
- 510(k) numbers
- ["K983974"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1000219614
- Firm city
- Marietta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28