Unifine Pentips 5mm x 31G pen needles — Class II medical device recall Z-0381-2018
Terminated recall by Owen Mumford USA, Inc., reported 2018-01-24, distributed nationwide. Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise steril
| Recall number | Z-0381-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Owen Mumford USA, Inc., Marietta, GA, United States |
| Recall initiated | 2017-11-06 |
| Classified | 2018-01-17 |
| Reported by FDA | 2018-01-24 |
| Terminated | 2021-02-12 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00384703550018 |
| Lot numbers | 1705122.S929, 1705722.S846, 3550, 3550AC |
Product
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.
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.
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-0381-2018. 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.