American Contract Systems recalls laparoscopy and pelviscopy kits with model numbers EVLP61I and EVPV29G due to unverified sterilization. Products may not meet safety standards after use.
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 labeled as laparoscopy packs and pelviscopy kits. The recall is because some components may not be properly sterilized, which could lead to infections or other health risks if used.
The company found that the sterilization process for some parts wasn't properly validated. This means the kits might not be safe for reuse after sterilization, potentially causing infections or other health issues.
Healthcare professionals and medical facilities that use these kits for procedures. Those handling the specific model numbers and lot numbers listed are most at risk.
Check for laparoscopy packs labeled with model EVLP61I or pelviscopy kits labeled with model EVPV29G. Look for the specific lot numbers listed in the recall notice.
Look for the model numbers EVLP61I or EVPV29G on the kit labels.
American Contract Systems determined that the sterilization of some components wasn't properly validated, so the kits may not meet safety standards.
The recall notice doesn't specify a remedy, so check the product labels and contact the manufacturer for further instructions.
Yes, the recall includes specific lot numbers for each model, which are listed in the notice.
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-2470-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2470-2025 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.
