The Recall Desk
HighFDA (Devices)·Z-0112-2023·Announced 2022-10-26

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.

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 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
Hazard
  • material-defect
  • device-integrity

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.

Related recalls

Same category