Medicina Reusable Oral Syringe recalled for incorrect plunger material
Medicina Uk Ltd is recalling Medicina Reusable Oral Syringe 2.5ml units because plunger components were manufactured with polyethylene instead of the specified polypropylene material.
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: This is a Class II medical device recall where the plunger component does not meet material specification due to substitution of unapproved material. While the defect creates a risk of plunger malfunction or performance issues, no injuries or illnesses have been reported.
Plain-English summary
Medicina Uk Ltd is recalling certain batches of Medicina Reusable Oral Syringe 2.5ml (Code: OTH25). The plunger component in these syringes was manufactured with polyethylene instead of polypropylene, the material specified in the product design. The affected batches are HM18042, HM21019, and HM21054, with approximately 2000 syringes distributed nationwide.
The use of an unapproved material means the syringes do not meet raw material specifications. This defect may affect plunger performance and reliability, potentially impacting proper functionality and accurate dosing.
No illnesses or injuries related to this issue have been reported. Consumers and healthcare facilities who have these syringes should contact Medicina Uk Ltd for instructions on replacement or proper disposal.
The recalled product
- Product
- Medicina Reusable Oral syringe 2.5ml Code: OTH25
- 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 (3)
- UDI-DI: (01)05056115402876 Batch number: HM18042
- HM21019
- HM21054
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.
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