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
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.
Part of a larger recall action
This product is one of 8 recalled by Medicina Uk Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Medicina Uk Ltd
See all →- HighMedicina Oral Tip Syringe recalled for unapproved plunger material
FDA (Devices) · 2022-10-26
- HighReusable Oral Syringe Recalled for Unapproved Plunger Material
FDA (Devices) · 2022-10-26
- HighMedicina Oral Tip Syringe Recall Due to Unapproved Plunger Material
FDA (Devices) · 2022-10-26
- ModerateMedicina ENFit Enteral Syringes Recalled for Incorrect Plunger Material
FDA (Devices) · 2022-10-26
- HighOral Tip Syringes Recalled Due to Unapproved Plunger Material
FDA (Devices) · 2022-10-26
Same hazard · material defect
See all →- LowParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- ModerateParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- HighNexxZr dental zirconia discs may have reduced or missing dentin layer
FDA (Devices) · 2026-06-17
- HighMAC two-lumen central venous kits recalled over incorrectly manufactured adhesive
FDA (Devices) · 2026-04-29
- HighArrowg+ard Blue Plus four-lumen CVC kits recalled over adhesive manufacturing
FDA (Devices) · 2026-04-29