The Recall Desk
HighFDA (Devices)·Z-0073-2025·Announced 2024-10-23

Merit Medical StabiliT TOUCH Syringe Sterile Barrier Defect Recall

Merit Medical Systems is recalling 202 StabiliT TOUCH Syringes with potential small holes in the sterile barrier. Affected devices may expose users to pathogens and pyrogens, which could cause infection.

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: FDA Class II medical device recall with potential for serious harm (infection via pathogen exposure) but no reported illnesses or injuries. The defect presents a high-risk scenario involving contamination of a sterile medical device.

Plain-English summary

Merit Medical Systems, Inc. is recalling 202 StabiliT TOUCH Syringes (reference number IN8VCF/B) due to a manufacturing defect in the sterile barrier.

The affected syringes may contain a small hole in the sterile barrier. During use, this defect could allow exposure to pathogens and pyrogens, potentially resulting in infection.

The affected devices were distributed worldwide, including throughout the United States and to France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, and Japan. Affected lot numbers are H2918440 (expiring 5/31/2027) and H2938015 (expiring 7/26/2027).

The recalled product

Product
StabiliT TOUCH Syringe, REF: IN8VCF/B
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Injection Device
Hazard
  • sterile-barrier-breach
  • pathogen-exposure
  • infection-risk

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 (2)

  • REF/UDI-DI/Lot(Expiration): IN8VCF/B/00884450662144/H2918440(5/31/2027)
  • H2938015(7/26/2027).

Distribution

Distributed nationwide across the United States.

Related recalls

Same category