The Recall Desk
HighFDA (Devices)·Z-0109-2023·Announced 2022-10-26

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.

What this means for you

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
  • material-defect

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.

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