Merit Medical recalls Custom Inflation Kits with serial numbers K05-00052M to K05-03150. Affected kits may have a small hole in the sterile barrier, risking pathogen exposure and infection.
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 certain Custom Inflation Kits that may have a small hole in the sterile barrier. Using these kits could expose users to pathogens or pyrogens, increasing infection risk.
The recall states that some kits may have a small hole in the sterile barrier. This hole could allow pathogens or pyrogens to enter the device, potentially leading to infection if used.
Users of the recalled Custom Inflation Kits are most at risk if they have the specific serial numbers listed in the recall. This includes medical device users who rely on these kits for procedures.
Check if your Custom Inflation Kit has a serial number starting with K05- followed by the specific model codes listed in the recall (e.g., K05-00052M, K05-00053H).
Look for the serial numbers listed in the recall (e.g., K05-00052M, K05-00053H) on your Custom Inflation Kit.
The recall does not specify a stop-use instruction. You can continue using the kit if it has a different serial number.
Check the serial number on your kit against the list of affected model codes provided in the recall.
The recall does not provide a remedy. You should contact Merit Medical for further instructions.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0070-2025 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0070-2025 from Merit Medical. 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.
