Steris recalls VERIFY Steam Test Packs (S3065) with inconsistent biological indicators that may falsely show sterilization cycles as effective when they are not. Affected units were sold in 2023 with 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 Packs (20 Tests and 5 controls) because some biological indicators may not properly show if sterilization cycles work. This could mean cycles are thought to be effective when they're actually not, risking unsafe medical equipment.
The biological indicators (BIs) in these test packs may not grow bacteria as expected. If a cycle appears effective but isn't, medical equipment could become contaminated with harmful pathogens.
Healthcare facilities using steam or ethylene oxide sterilization equipment are most at risk. The affected units were sold with lot number 230613 in 2023.
Check for the item number S3065 on the package. The recall covers units sold with lot number 230613 in 2023.
Look for item number S3065 and lot number 230613 on the package.
The biological indicators in these test packs may not grow bacteria as expected, which could mean sterilization cycles appear effective when they are not.
Check for item number S3065 and lot number 230613 on the package.
The recall record does not specify a remedy, so contact Steris Corporation directly 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-0780-2023 — Steris Steris Hello, I own a Steris that is covered by recall Z-0780-2023 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.
