The Recall Desk
HighFDA (Devices)·Z-0066-2025·Announced 2024-10-23

DiamondTOUCH Digital Inflation Device Sterile Barrier Defect Recall

Merit Medical Systems is recalling the DiamondTOUCH Digital Inflation Device due to a small hole in the sterile barrier. The defect may expose patients to pathogens or pyrogens, potentially causing 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 no reported illnesses or injuries. The sterile barrier defect presents a significant risk of infection from pathogen/pyrogen exposure, meeting the criteria for High severity as a risk-of-harm product without yet-reported injury.

Plain-English summary

Merit Medical Systems, Inc. is recalling the DiamondTOUCH Digital Inflation Device (REF: IN9135/A, IN9152/A). The devices may have a small hole in the sterile barrier.

If the sterile barrier is compromised, patients using the device may be exposed to pathogens or pyrogens, which could lead to infection. A total of 290 affected units have been distributed worldwide, including throughout the United States and internationally to France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, and Japan.

Healthcare facilities and practitioners should contact Merit Medical Systems for further guidance regarding affected devices.

The recalled product

Product
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Inflation Device
Hazard
  • sterile-barrier-defect
  • pathogen-exposure
  • infection-risk

Distribution

Distributed nationwide across the United States.

Related recalls

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