FDA Device recall Z-0107-2023
Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
- FDA Device
- Class II
- ongoing
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD 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-0107-2023 |
| 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 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
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)05060278508146 Batch number: HM17121, HM18051, HM18080, HM18120, HM18141, HM19007, HM19016, HM19059, HM190…UDI-DI: (01)05060278508146 Batch number: HM17121, HM18051, HM18080, HM18120, HM18141, HM19007, HM19016, HM19059, HM19083, HM19130, HM19144, HM20005, HM20054, HM21044, HM22018 |
|---|
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-0107-2023%22
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