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.
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 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.
- Affected units
- 429
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
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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