Class II — Owen Mumford USA, Inc.
| Recalling firm | OWEN MUMFORD LTD. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover. |
| Quantity | 2,593 cartons of 100 ea. |
| Distribution | 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. |
| Initiated | 2021-05-26 |
| Classified | 2021-07-15 |
| Recall number | Z-2078-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Owen Mumford USA, Inc. (Z-2078-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88013/
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