Steris recalls VERIFY Dual Species Self-Contained Biological Indicators (S3060) due to inconsistent growth of spores, which may falsely indicate sterilization cycles are effective when they are not.
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 Indicators because some units fail to show proper growth of spores during sterilization testing. This could lead to ineffective sterilization cycles being mistakenly thought to be working, potentially risking contamination.
The biological indicators may not grow spores consistently, causing false positives that suggest sterilization cycles are effective when they are actually failing. This could lead to contaminated medical equipment being used.
Healthcare facilities using these indicators for steam or ethylene oxide sterilization monitoring are most at risk. The recall affects specific lots produced in 2023.
Check for the item number S3060 on the packaging. The recall covers specific lots produced in 2023, with the lot number 230613.
Look for the item number S3060 and lot number 230613 on the packaging.
The biological indicators may not grow spores consistently, which could lead to false indications that sterilization cycles are effective when they are not.
Check the item number and lot number on the packaging. If it matches S3060 and lot 230613, contact Steris for guidance.
The recall addresses potential contamination risks from ineffective sterilization, but the hazard does not involve direct injury to users.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-0778-2023 — Steris Steris Hello, I own a Steris that is covered by recall Z-0778-2023 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.
