Merit Medical recalls basixTOUCH Inflation Devices with potential small hole in sterile barrier that could expose users to pathogens, leading to infection. 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 basixTOUCH Inflation Devices that may have a small hole in the sterile barrier. This could expose users to pathogens or pyrogens, increasing infection risk. Affected devices have specific lot numbers and expiration dates.
The sterile barrier of the device may have a small hole, allowing pathogens or pyrogens to enter. This exposure could lead to infection or other health issues if the device is used without proper sterilization.
Users of basixTOUCH Inflation Devices who purchased the affected lot numbers between 2022 and 2027 are likely affected. Healthcare professionals using these devices for medical procedures face the highest risk.
Check the device for lot numbers starting with IN8140/A followed by specific numbers like 00884450627105, 00884450627106, etc. The expiration dates range from April 2022 to December 2026.
Look for the lot number on the device label, which starts with IN8140/A followed by specific numbers.
Using affected devices may expose users to pathogens or pyrogens, which could lead to infection.
Check the lot number on the device label; affected units have specific lot numbers starting with IN8140/A followed by numbers like 00884450627105, 00884450627106, etc.
The recall does not specify a remedy, so contact Merit Medical directly for guidance.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0065-2025 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0065-2025 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.
