Medicina ENFit enteral syringe recall due to material specification defect
Medicina is recalling ENFit 1ml enteral syringes because the plunger was manufactured with polyethylene instead of approved polypropylene. This material defect could affect plunger function and device safety.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a material specification defect in a medical device where the plunger was manufactured with an unapproved material (polyethylene instead of polypropylene). While no illnesses or injuries have been reported, the defect represents a structural risk to proper device function in a medical application.
Plain-English summary
Medicina Uk Ltd is recalling its ENFit 1ml Reusable Low Dose Enteral Syringes (Code: LHE01LD) nationwide. The plunger component in these syringes was manufactured with polyethylene instead of the approved polypropylene material, failing to meet manufacturing specifications.
The material defect could compromise the plunger's function, potentially affecting the device's safe use in enteral feeding applications. Syringes with batch numbers HM17121, HM18051, HM18080, HM18120, HM18141, HM19007, HM19016, HM19059, HM19083, HM19130, HM19144, HM20005, HM20054, HM21044, and HM22018 are affected, representing 9 boxes (900 units) in total.
If you have used these syringes, discontinue use and contact your healthcare provider or Medicina Uk Ltd for guidance on replacement or return.
The recalled product
- Product
- Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
- Manufacturer
- Medicina Uk Ltd
- Category
- Medical Device — Enteral Syringe
- Hazard
- material-defect
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- UDI-DI: (01)05060278508146 Batch number: HM17121
- HM18051
- HM18080
- HM18120
- HM18141
- HM19007
- HM19016
- HM19059
- HM19083
- HM19130
- HM19144
- HM20005
- HM20054
- HM21044
- HM22018
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Convenience Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- HighMedline Industries Polycarbonate Syringes Convenience Kits Design Change Recall
FDA (Devices) · 2026-07-01
- HighStryker Neurovascular INZONE Detachment System battery drain
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical burr recalled for potential breakage risk
FDA (Devices) · 2026-07-01
- ModerateThuvera Laser Console Software Version 2.2 Recall Notice
FDA (Devices) · 2026-07-01