The Recall Desk
HighFDA (Devices)·Z-0065-2025·Announced 2024-10-23

basixTOUCH Inflation Device Recalled for Sterile Barrier Defect

Merit Medical Systems is recalling the basixTOUCH Inflation Device (REF: IN8140/A) because devices may have a small hole in the sterile barrier, potentially exposing users to pathogens and pyrogens that could lead to 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: This is a Class II device with a significant risk-of-harm defect (sterile barrier compromise) that could lead to infection, but no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without reported injury receive a High rating.

Plain-English summary

Merit Medical Systems, Inc. is recalling the basixTOUCH Inflation Device (REF: IN8140/A), with approximately 1,952 units affected by this recall.

The recalled devices may have a small hole in the sterile barrier. Use of affected devices may result in exposure to pathogens and pyrogens, which could lead to infection.

The devices were distributed worldwide, including throughout the United States and internationally to France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, and Japan.

The recalled product

Product
basixTOUCH Inflation Device, REF: IN8140/A
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Inflation device
Hazard
  • sterile-barrier-defect
  • infection-risk
  • pathogen-exposure

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 (5)

  • REF/UDI-DI/Lot(Expiration): IN8140/A/00884450627105/H2925218(4/22/2027)
  • H2929411(4/29/2027)
  • H2938003(4/30/2027)
  • H2972592(4/30/2027)
  • H2982505(12/31/2026).

Distribution

Distributed nationwide across the United States.

Related recalls

Same category