Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VERIFY Dual Species Self-Contained Biological Indicators Recalled by Steris Corporation Due to Biological indicator (BI) used to promote growth of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Steris Corporation directly.
Affected Products
VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Quantity: 857 boxes
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Steris Corporation
Steris Corporation has 109 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report