FDA Device recall Z-0113-2023
Medicina Reusable Oral syringe 5ml Code: OTH05
- FDA Device
- Class II
- ongoing
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of Medicina Reusable Oral syringe 5ml Code: OTH05 by Medicina Uk, citing plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0113-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-04 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medicina Uk |
| Distribution | US |
Product
Medicina Reusable Oral syringe 5ml Code: OTH05
Reason
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
Identifiers
| code_info | UDI-DI: (01)05056115403491 (01)05056115403491(17)260700(10)HM21055 Batch number: HM18043, HM20020, HM21055 |
|---|
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-0113-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.