FDA Device recall Z-0108-2023
Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05
- FDA Device
- Class II
- ongoing
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05 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-0108-2023 |
| 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 ENFit 5ml Reusable Enteral Syringe Code: LHE05
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)05060278508153(17)250400(10)HM20055 Batch number: HM17099, HM18010, HM18052, HM18103, HM18113, HM18143, HM…UDI-DI: (01)05060278508153(17)250400(10)HM20055 Batch number: HM17099, HM18010, HM18052, HM18103, HM18113, HM18143, HM19009, HM19018, HM19061, HM19084, HM19132, HM19146, HM20006, HM20032, HM20055, HM20095, HM21037, HM21069, HM22019 |
|---|
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-0108-2023%22
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