Z-2082-2015Class II

Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC...

Name: Z-2082-2015 Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC...
Creator: Owen Mumford USA, Inc.
Published: 2014-12-11
License: https://open.fda.gov/license/

Owen Mumford USA, Inc. / initiated 2014-12-11 / Terminated / root cause: manufacturing process

FDA source

Owen Mumford USA, Inc. began a recall of 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... on 2014-12-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2082-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-11
Posted: 2015-07-15
Terminated: 2017-07-11
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.
Product code: FMF Syringe, Piston
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 225 units
Distribution: Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
Product codes and lots: Lot 7JH, UPC Code 384703800014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2082-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2082-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-15

Product code FMF

K983974Class IIOwen Mumford 3Ml AutopenOwen Mumford USA, Inc. / cleared 1998-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)