Medicina Reusable Oral syringe 1ml Code: OTH01 — Class II medical device recall Z-0112-2023
Ongoing recall by Medicina Uk Ltd, reported 2022-10-26, distributed nationwide. Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does
| Recall number | Z-0112-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medicina Uk Ltd, Bolton, N/A, United Kingdom |
| Recall initiated | 2022-07-04 |
| Classified | 2022-10-20 |
| Reported by FDA | 2022-10-26 |
| Distributed | Nationwide (US) |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 05056115402869 |
| Lot numbers | HM18041, HM21053 |
Product
Medicina Reusable Oral syringe 1ml Code: OTH01
Reason for recall
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
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-0112-2023. 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.