Owen Mumford USA, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0381-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.

Product Classification:

Class II

Date Initiated: November 6, 2017

Date Posted: January 24, 2018

Recall Number: Z-0381-2018

Event ID: 78483

Reason for Recall:

Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.

Status: Terminated

Product Quantity: 2,660 cartons (266,000 pen needles)

Code Information:

UPC #384703550018: Batch No. AN 3550, Lot No. 1705722.S846; Batch No. AN 3550AC, Lot No. 1705122.S929.

Distribution Pattern:

US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH NJ, NY, OH, OK, PA, TN, NX, UT, VA, VT, WA, WV

Voluntary or Mandated:

Voluntary: Firm initiated