CLASS II ONGOING Device recall · Reported 26 Oct 2022 · FDA Enforcement Report
Medicina Oral Tip Syringe recalled by Medicina Uk
Medicina Uk is recalling Medicina Oral Tip Syringe, 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-0110-2023
- 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 Oral Tip Syringe 1ml Code: OT01
Where it was distributed
Nationwide
Questions about this recall
Is Medicina Oral Tip Syringe recalled?
Yes. Medicina Uk recalled Medicina Oral Tip Syringe on 4 Jul 2022. The recall is Class II and its status is Ongoing. Recall number Z-0110-2023.
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)05060278503424 Batch number: HM18147, HM19012, HM19025, HM19088, HM19164, HM20063 HM21015, HM21072
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 Reusable Oral syringe recalled by Medicina Uk | Medicina Uk | Device Malfunction | Nationwide |
| Device | CLASS II | Medicina ENFit Reusable Enteral 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 |
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| 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 |