FDADecember 12, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

steris

UPCs

1072499502383350724995023824

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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