American Contract Systems Inc. has recalled 32,433 units of various medical convenience kits and biopsy trays because they were sterilized with Ethylene Oxide gas more than once. These products, which are used in a variety of surgical and diagnostic procedures, have not been validated for safety or effectiveness after undergoing multiple sterilization cycles. The recall includes kits used for biopsy, robotic surgery, laparoscopy, cardiology, orthopedics, and labor and delivery. Because the materials and performance of the devices have not been tested for double sterilization, their quality and safety cannot be confirmed. These products were distributed to healthcare facilities in Iowa, Illinois, Minnesota, South Dakota, and Washington.
Sterilizing medical devices more than once can degrade materials or leave chemical residues that have not been evaluated for safety. This poses a potential risk to patients, as the effectiveness of the surgical tools or the sterile barrier of the kits could be compromised, potentially leading to surgical complications or infections.
Entire lot impacted.
If 'N/A' for bag serial number, the whole lot is affected.
If 'N/A' for bag serial number, then whole lot is affected.
If Bag serial number is listed as 'N/A', then whole lot is affected.
If bag serial number is 'n/a', then all of that lot is affected.
If bag serial number is 'n/a', then all of that lot is affected.
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.