Medicina Reusable Oral Syringe Recalled for Unapproved Plunger Material
Medicina Uk Ltd is recalling Medicina Reusable Oral syringes because the plunger was manufactured with polyethylene instead of the required polypropylene material. The 11,100 affected syringes do not meet raw material specifications.
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 an FDA Class II medical device recall for a material specification defect with no reported injuries, illnesses, or hospitalizations. The use of unapproved material in a critical syringe component represents a risk-of-harm scenario where the hazard is potential but not yet realized, meeting the criteria for High severity.
Plain-English summary
Medicina Uk Ltd is recalling Medicina Reusable Oral syringes 1ml (Code OTH01). The recall affects 111 boxes containing 11,100 units distributed nationwide. Affected batch numbers are HM18041 and HM21053, identified by UDI-DI code (01)05056115402869(17)260700(10)HM21053.
The plunger component in these syringes was manufactured using polyethylene instead of the required polypropylene material. This composition fails to meet the product's raw material specifications.
Individuals and healthcare facilities in possession of affected syringes should contact Medicina Uk Ltd for further instructions regarding this recall.
The recalled product
- Product
- Medicina Reusable Oral syringe 1ml Code: OTH01
- Manufacturer
- Medicina Uk Ltd
- Category
- Medical Device — Oral 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 (1)
- HM21053
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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