Merit Medical recalls BlueFIRE Inflation Device REF IN10140 due to potential small hole in sterile barrier causing infection risk. Affected units sold with specific lot number and expiration date.
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 BlueFIRE Inflation Devices with reference number IN10140 because some units may have a small hole in the sterile barrier. This could expose users to pathogens or pyrogens, leading to infection. If you own this device, stop using it immediately and contact Merit Medical for instructions.
The device may have a small hole in the sterile barrier, which can allow pathogens or pyrogens to enter. Using these affected devices could lead to infection if the hole is present.
Users of BlueFIRE Inflation Devices with reference number IN10140 are affected. Those who have the device and use it for medical purposes are at higher risk of infection.
Check for the reference number IN10140 on the device. Affected units were sold with lot number 00884450363607 and expire on 4/30/2027.
Immediately stop using the BlueFIRE Inflation Device if it has the reference number IN10140.
Reach out to Merit Medical Systems for instructions on how to return or replace the device.
The recalled model is BlueFIRE Inflation Device with reference number IN10140.
Check for the reference number IN10140 on the device. Affected units have lot number 00884450363607 and expire on 4/30/2027.
The recall states a risk of infection from pathogens/pyrogens, not serious injury. The hazard level is use_caution.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0068-2025 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0068-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
