The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0072-2025·Announced 2024-10-23

basixTOUCH Inflation Device May Have Sterile Barrier Defect

Merit Medical Systems is recalling basixTOUCH Inflation Devices due to a potential hole in the sterile barrier. The defect may expose patients to pathogens and pyrogens, increasing infection risk.

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: FDA Class II medical device with potential exposure to pathogens and pyrogens that could lead to infection. No illnesses or deaths reported in the source text. Meets rubric criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Merit Medical Systems, Inc. is recalling the basixTOUCH Inflation Device (available under multiple reference numbers including IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, and IN8130/C) due to a manufacturing defect. The devices may contain a small hole in the sterile barrier, which could expose patients to pathogens and pyrogens.

The affected batch includes 16,439 units distributed worldwide. In the United States, the devices were distributed across all states. The devices also reached distribution partners in France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, and Japan. Specific lot numbers and expiration dates have been identified and can be used to determine if a device is affected.

Healthcare providers and patients who have received these devices should stop using them immediately. Contact Merit Medical Systems or your healthcare provider to report exposure or discuss potential infection risks. Patients who have already received an affected device should consult their healthcare provider about the need for medical evaluation.

The recalled product

Product
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Inflation Device
Hazard
Affected units
16,439

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 (19)

  • H2929412(4/29/2027)
  • H2938005(5/12/2027)
  • H2938006(5/12/2027)
  • H2943498(5/19/2027)
  • H2943499(5/19/2027)
  • H2972593(5/26/2027)
  • H2972594(5/26/2027)
  • H2934720(5/12/2027)
  • H2943517(5/19/2027)
  • H2972598(5/26/2027). IN8130/C/00884450621059/H2925215(4/22/2027)
  • H2929410(4/29/2027)
  • H2934714(5/5/2027)
  • H2937998(5/12/2027)
  • H2938000(5/12/2027)
  • H2943487(5/19/2027). IN8130/C/00884450621059/H2972590(5/26/2027)
  • H2978089(6/3/2027)
  • H2978090(6/3/2027)
  • H2978091(6/3/2027)
  • H2989571(6/17/2027).

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

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.

See all 10 products in this recall →

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