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.
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 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.
- Affected units
- 1,952
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
Part of a larger recall action
This product is one of 10 recalled by Merit Medical Systems, Inc. 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.
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