American Contract Systems recalls CYSTO Model SACY80: Unconfirmed sterilization may cause treatment delays or malfunction. Affected units have specific lot numbers.
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 CYSTO models SACY80R due to unconfirmed sterilization, which could cause treatment delays or device malfunction. This affects medical devices used for patient care.
The device may not be properly sterilized, leading to potential treatment delays or malfunction. This could impact patient care if the device fails during use.
Patients using CYSTO medical devices for treatment may be affected. Healthcare providers using these devices are most at risk of treatment delays.
Check for the model number SACY80R on the device. Affected units have lot numbers 70-51139, 70-052248, 70-052564, or 70-052954.
Look for the model number SACY80R on the device.
The manufacturer cannot confirm that the device was properly sterilized, which may cause treatment delays or malfunction.
Check the model number and lot numbers to see if your device is affected. The recall does not require immediate action beyond checking.
The recall states possible treatment delays or malfunction, but no specific injury risk is mentioned.
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-1346-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1346-2025 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.
