Medicina Oral Tip Syringe Recall Due to Unapproved Plunger Material
Medicina Uk Ltd is recalling 12,000 Oral Tip Syringes (Code: OT005) because the plunger component was manufactured with polyethylene instead of the approved polypropylene material. The 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 FDA Class II medical device recall involves a material specification defect in the plunger component. No illnesses or injuries have been reported, which limits the maximum score to 3 per the rubric. The FDA Class II classification reflects the agency's determination that the product defect could result in health consequences.
Plain-English summary
Medicina Uk Ltd is recalling 120 boxes containing 12,000 Medicina Oral Tip Syringe 0.5ml units (Code: OT005) distributed nationwide. The plunger component in these syringes was manufactured with polyethylene instead of the approved polypropylene material and does not meet the required raw material specifications.
The affected syringes have batch number HM19024 (UDI-DI: 05060278503417). Consumers and healthcare providers who have these syringes should discontinue use and contact Medicina Uk Ltd for instructions on replacement or safe disposal.
The recalled product
- Product
- Medicina Oral Tip Syringe 0.5ml Code: OT005
- Manufacturer
- Medicina Uk Ltd
- Category
- Medical Device — Syringe
- Hazard
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)
- UDI-DI: (01)05060278503417 Batch number: HM19024
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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