American Contract Systems recalls medical procedure kits and trays due to unverified sterilization. Products labeled CYSTO with specific model numbers and lot numbers may not meet sterilization standards.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
American Contract Systems is recalling medical procedure kits and trays labeled CYSTO because some components were not properly sterilized. This could lead to infections if the products are used without confirmed sterilization.
The recall is due to ACS finding that some components were not properly sterilized as per their procedures. This means the products may not meet sterilization assurance requirements, potentially leading to infections if used.
Healthcare professionals and medical facilities using the recalled CYSTO kits and trays with specific model numbers and lot numbers are most at risk. Patients using these products could face infection risks.
Check for CYSTO kits and trays with model numbers ASCY24A, BUCY78E, LMCP22T, LMTU31T, SACY80S, or SPUR64F. Look for specific lot numbers listed in the recall notice.
Identify the model number and lot numbers from the product labels to confirm if it is recalled.
American Contract Systems determined that some components were not properly sterilized according to their procedures, so they cannot confirm the products meet sterilization standards.
The affected models include CYSTO with specific model numbers (ASCY24A, BUCY78E, LMCP22T, LMTU31T, SACY80S, SPUR64F) and the listed lot numbers.
The recall does not require immediate stop use; however, you should check if your product is affected and verify sterilization status.
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2466-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2466-2025 from American Contract Systems. 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.
