Owen Mumford USA, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2082-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 11, 2014

Date Posted: July 22, 2015

Recall Number: Z-2082-2015

Event ID: 70783

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.

Status: Terminated

Product Quantity: 225 units

Code Information:

Lot 7JH, UPC Code 384703800014

Distribution Pattern:

Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.

Voluntary or Mandated:

Voluntary: Firm initiated