Steris recalls VERIFY Dual Species Self-Contained Biological Indicators due to inconsistent growth promotion in sterilization cycles, risking false effective sterilization readings.
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 VERIFY Dual Species Self-Contained Biological Ind: 100 per box (Item S3061) because some units may not properly indicate if sterilization cycles worked. This could lead to unsafe conditions if the sterilization process failed but the indicator showed it was effective.
The biological indicator may not show growth when sterilization cycles are actually ineffective. This could mean the sterilization process failed but the indicator incorrectly shows it worked, potentially leaving medical equipment unsafe.
Healthcare facilities using these indicators for steam or ethylene oxide sterilization monitoring are likely affected. Staff handling sterilization processes face the highest risk.
Look for the VERIFY Dual Species Self-Contained Biological Indicators with Item Number S3061. They were sold in lots labeled #230613 and contain 100 units per box.
Verify if your indicator shows growth when exposed to sterilization cycles by testing with a known effective cycle.
The biological indicators may not consistently show growth, which could mean sterilization cycles failed but the indicator incorrectly shows they worked.
The recall record does not specify a remedy, so no action is required beyond checking if the indicator shows growth.
The recalled items have Item Number S3061 and were sold in lot #230613 with 100 units per box.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-0779-2023 — Steris Steris Hello, I own a Steris that is covered by recall Z-0779-2023 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.
