FDA Device recall Z-2078-2021
Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover
- FDA Device
- Class II
- ongoing
- Published 2021-07-21
On 2021-07-21 the FDA classified a Class II recall of Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover by Owen Mumford Usa, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2078-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-26 |
| Published | 2021-07-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Owen Mumford Usa |
| Distribution | US |
Product
Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
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.
Identifiers
| code_info | Lot numbers: 20V4001.Z3999, Lot 20V4001.Z4019 and 20V4001.Z411 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2078-2021%22
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