Merit Medical recalls IntelliSystem Inflation Device REF IN1525/D due to potential small hole in sterile barrier causing infection risk. Affected units have specific lot numbers and expiration dates.
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Merit Medical is recalling IntelliSystem Inflation Devices with a possible small hole in the sterile barrier that could expose users to infection. This recall affects specific model numbers and lot dates.
The inflation device may have a small hole in the sterile barrier, which could allow pathogens or pyrogens to enter the device. Using affected devices might lead to infection if the device is not properly sterilized.
Users of IntelliSystem Inflation Devices with the specific lot numbers and expiration dates listed in the recall are affected. Healthcare professionals and patients using these devices are at risk of infection.
Check for the product reference number IN1525/D and lot numbers H2918426 (expiring 4/22/2027) or H2934697 (expiring 1/31/2027) on the device packaging.
Look for lot numbers H2918426 (expiring 4/22/2027) or H2934697 (expiring 1/31/2027) on the device packaging.
The recalled device is IntelliSystem Inflation Device with reference number IN1525/D.
Check for lot numbers H2918426 (expiring 4/22/2027) or H2934697 (expiring 1/31/2027) on the device packaging.
The recall does not specify a remedy, so contact Merit Medical Systems for further instructions.
We’ve drafted a message you can send Merit Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0067-2025 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-0067-2025 from Merit Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
