Unifine Pentips Plus — Class II medical device recall Z-2078-2021
Ongoing recall by Owen Mumford USA, Inc., reported 2021-07-21, distributed nationwide. Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of
| Recall number | Z-2078-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Owen Mumford USA, Inc., Marietta, GA, United States |
| Recall initiated | 2021-05-26 |
| Classified | 2021-07-15 |
| Reported by FDA | 2021-07-21 |
| Distributed | Nationwide (US) |
| Lot numbers | 20V4001.Z3999, 20V4001.Z4019, 20V4001.Z411 |
Product
Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2078-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.