American Contract Systems recalls medical procedure kits with unverified sterilization. Some components may not be sterilized properly, risking infection. Affected kits have specific model numbers and lot codes.
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 two medical procedure kits because some components may not have been properly sterilized. This could lead to infections if the kits are used in medical procedures.
The recall states that the sterilization process for some components was not properly verified. This means the kits might not be sterile, increasing the risk of infection during medical procedures.
Healthcare professionals using the recalled medical kits are most at risk. Patients receiving procedures with these kits could be exposed to infection.
Check for model numbers UICR10W or UISH55V on the kits. Lot numbers include 42-7799111 through 42-8140711 for both models.
Identify the model number on the kit (UICR10W or UISH55V) and check the lot number against the listed numbers.
The manufacturer determined that the sterilization of some components was not properly verified, so they cannot confirm the kits meet sterilization requirements.
Check the model and lot numbers to see if it's affected. If it is, contact American Contract Systems for further instructions.
Yes, because the kits may not be properly sterilized, which could lead to infections during medical procedures.
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-2468-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2468-2025 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.
