Merit Medical Systems, Inc. is recalling 4,686,721 units of various inflation devices and custom procedure kits because the handle may detach from the syringe during medical procedures. This recall affects a wide range of products including the basixCOMPAK and Allwell inflation device lines, as well as several custom waste management, manifold, and procedure kits. The devices were distributed worldwide between December 2024 and late 2025.
If the inflation device handle detaches during a medical procedure, it may lead to a loss of pressure or the inability to control the device. This defect could cause significant delays in a surgical procedure or potential patient injury if clinical intervention is interrupted.
Recall Number: Z-1123-2026. This extensive list covers various basixCOMPAK inflation device configurations.
Recall Number: Z-1124-2026.
Recall Number: Z-1125-2026.
Recall Number: Z-1126-2026.
Recall Number: Z-1127-2026.
Recall Number: Z-1128-2026.
Recall Number: Z-1129-2026.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.