CLASS II ONGOING Device recall · Reported 26 Oct 2022 · FDA Enforcement Report
Medicina ENFit Reusable Enteral Syringe recalled by Medicina Uk
Medicina Uk is recalling Medicina ENFit Reusable Enteral, distributed nationwide in the US. The recall was initiated on 4 Jul 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0108-2023
- FDA event ID
- 90849
- Recalling firm
- Medicina Uk, Bolton, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Jul 2022
- FDA classified
- 20 Oct 2022
- Reported
- 26 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Syringes & Needles
Timeline
| 4 Jul 2022 | Recall initiated by company | |
| 20 Oct 2022 | Classified by FDA | +108 days |
| 26 Oct 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
Which lots are affected?
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
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 90849This product is part of a recall event; the main page for the event is Medicina Oral Tip Syringe recalled by Medicina Uk.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medicina Oral Tip Syringe recalled by Medicina Uk | Medicina Uk | Device Malfunction | Nationwide | |
| CLASS II | Medicina ENFit Reusable Low Dose Enteral Syringe recalled by Medicina Uk | Medicina Uk | Device Malfunction | Nationwide | |
| CLASS II | Medicina Oral Tip Syringe recalled by Medicina Uk | Medicina Uk | Device Malfunction | Nationwide | |
| CLASS II | Medicina Reusable Oral syringe recalled by Medicina Uk | Medicina Uk | Device Malfunction | Nationwide | |
| CLASS II | Medicina Oral Tip Syringe recalled by Medicina Uk | Medicina Uk | Device Malfunction | Nationwide | |
| CLASS II | Medicina Reusable Oral syringe recalled by Medicina Uk | Medicina Uk | Device Malfunction | Nationwide | |
| CLASS II | Medicina Reusable Oral syringe recalled by Medicina Uk | Medicina Uk | Device Malfunction | Nationwide |
More recalls from Medicina Uk
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medicina Reusable Oral syringe recalled by Medicina Uk | Medicina Uk | Device Malfunction | Nationwide |
| Device | CLASS II | Medicina Reusable Oral syringe recalled by Medicina Uk | Medicina Uk | Device Malfunction | Nationwide |
| Device | CLASS II | Medicina Oral Tip Syringe recalled by Medicina Uk | Medicina Uk | Device Malfunction | Nationwide |
| Device | CLASS II | Medicina Reusable Oral syringe recalled by Medicina Uk | Medicina Uk | Device Malfunction | Nationwide |
| Device | CLASS II | Medicina Oral Tip Syringe recalled by Medicina Uk | Medicina Uk | Device Malfunction | Nationwide |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |