American Contract Systems recalls C-SECTION PPS models LLCI66M-02 to -04 due to possible sterilization issues causing treatment delays. No remedy provided in official notice.
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
American Contract Systems is recalling specific C-SECTION PPS models because they may not have been properly sterilized, which could delay or prolong medical treatment. This is a safety issue for patients using these devices during surgery.
The device may not have been properly sterilized during manufacturing, which could lead to treatment delays or prolonged procedures. This happens because the sterilization process is critical for medical devices to be safe and effective.
Patients using the C-SECTION PPS surgical device during procedures. Those with the specific model numbers LLCI66M-02 through LLCI6:6M-04 are most at risk.
Check for model numbers LLCI66M-02, LLCI66M-03, or LLCI66M-04 on the device. The product was sold with specific lot numbers between 2007 and 2008.
Look for model numbers LLCI66M-02, LLCI66M-03, or LLCI66M-04 on the device.
The manufacturer cannot confirm that the device was properly sterilized, which could cause treatment delays or prolonged procedures.
No remedy is provided in the official recall notice.
Check for model numbers LLCI66M-02, LLCI66M-03, or LLCI66M-04 on the device. The product was sold with specific lot numbers between 2007 and 2008.
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-1342-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1342-2025 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.
