Steris recalls VERIFY Steam Test Pack (20 Tests) due to inconsistent biological indicator growth. This could lead to false indication of sterilization effectiveness, risking infection. Affected units have item number S3069 and lot #230613.
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
Steris is recalling its VERIFY Steam Test Pack (20 Tests and 20 controls) because some units fail to show proper bacterial growth. This means the test might incorrectly indicate sterilization worked when it didn't, potentially leading to infections.
The biological indicator (BI) used to test sterilization cycles may not grow bacteria properly. If it shows no growth, the system might be thought to be sterilized when it isn't, increasing infection risk.
Healthcare facilities using steam or ethylene oxide sterilization equipment are most likely affected. Users must check if their unit has item number S3069 and lot #230613.
Check for item number S3069 and lot number 230613 on the package. The product is intended for use in healthcare sterilization testing.
Look for item number S3069 and lot number 230613 on the package.
The biological indicator may not grow bacteria consistently, which could lead to false indications that sterilization cycles worked when they didn't.
Check for item number S3069 and lot number 230613 on the package.
The recall record does not specify a remedy, so contact Steris Corporation for guidance.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-0781-2023 — Steris Steris Hello, I own a Steris that is covered by recall Z-0781-2023 from Steris. 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.
