The Recall Desk
HighFDA (Devices)·Z-0067-2025·Announced 2024-10-23

IntelliSystem Inflation Device from Merit Medical Recalled for Sterile Barrier Defect

Merit Medical Systems is recalling 429 IntelliSystem Inflation Devices due to a potential hole in the sterile barrier that could allow pathogen exposure and 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 an FDA Class II medical device recall with a structural defect in the sterile barrier. While no reported illnesses or deaths are mentioned in the source, the device poses a risk-of-harm through potential exposure to pathogens and pyrogens, meeting the criterion for a High severity rating.

Plain-English summary

Merit Medical Systems, Inc. is recalling the IntelliSystem Inflation Device, model IN1525/D, due to a defect in the sterile barrier. Approximately 429 units have been distributed.

The affected devices may contain a small hole in the sterile barrier that could compromise sterility. Use of affected devices may expose the sterile field to pathogens and pyrogens, which could lead to infection.

The devices were distributed worldwide, including throughout all U.S. states and to France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, and Japan. The specific lot numbers and expiration dates of the affected devices are available in the FDA recall information.

The recalled product

Product
IntelliSystem Inflation Device, REF: IN1525/D
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Inflation Device
Hazard
  • sterile-barrier-defect
  • pathogen-exposure
  • pyrogen-exposure
  • infection

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): IN1525/D/00884450298015/ H2918426(4/22/2027)
  • H2934697(1/31/2027)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category