Autopen Classic Automatic insulin delivery pen, 3.0ml x 2… recallZ-2082-2015 · Owen Mumford USA, Inc. · initiated Dec 11, 2014
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Owen Mumford USA, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2082-2015
- Status
- Terminated
- Initiated by the company
- Dec 11, 2014
- Posted by the FDA
- Jul 15, 2015
- Recalling firm
- Owen Mumford USA, Inc.
- Quantity
- 225 units
- Product code
- FMF
- FDA submissions
- K983974
- Distribution
- Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
Product description
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.
Code information (models, lots, serial numbers)
Lot 7JH, UPC Code 384703800014
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Autopen AN3800Owen Mumford Limited · Syringe, Piston1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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