Oral Tip Syringes Recalled Due to Unapproved Plunger Material
Medicina Oral Tip Syringes are being recalled because the plunger component was made with polyethylene instead of the approved polypropylene material. No illnesses or injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device recall involving a material specification failure in a critical component (unapproved polyethylene plunger instead of polypropylene). This is a risk-of-harm product where no illnesses or injuries have been reported, placing it at the maximum threshold for theoretical hazard recalls.
Plain-English summary
Medicina Uk Ltd is recalling Medicina Oral Tip Syringe 1ml (Code: OT01) due to a material defect in the plunger component. A total of 2,900 syringes across 29 boxes have been distributed nationwide.
The plunger component was manufactured using polyethylene instead of the approved polypropylene material, failing to meet the manufacturer's raw material specifications. This material substitution could affect the proper function and performance of the syringe.
The recall affects syringes from batch numbers HM18147, HM19012, HM19025, HM19088, HM19164, HM20063, HM21015, and HM21072. No illnesses or injuries have been reported. Patients and healthcare providers should verify batch numbers and contact Medicina Uk Ltd if they have received affected units.
The recalled product
- Product
- Medicina Oral Tip Syringe 1ml Code: OT01
- Manufacturer
- Medicina Uk Ltd
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 (7)
- UDI-DI: (01)05060278503424 Batch number: HM18147
- HM19012
- HM19025
- HM19088
- HM19164
- HM20063 HM21015
- HM21072
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
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