Owen Mumford USA, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2078-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.
Product Description:

Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.

Product Classification:

Class II

Date Initiated: May 26, 2021
Date Posted: July 21, 2021
Recall Number: Z-2078-2021
Event ID: 88013
Reason for Recall:

Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.

Status: Ongoing
Product Quantity: 2,593 cartons of 100 ea.
Code Information:

Lot numbers: 20V4001.Z3999, Lot 20V4001.Z4019 and 20V4001.Z411

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, TX, UT, VA, VT, WA, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated