Steris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
Steris Corporation is recalling VERIFY Dual Species Self-Contained Biological Indicators because the spore population may fall below specifications, potentially leading to false sterilization results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a Class II medical device where the biological indicator may fail to detect ineffective sterilization cycles, posing a risk of harm if used, but the source does not report any illnesses, injuries, or deaths.
Plain-English summary
Steris Corporation is recalling 2,205 units of VERIFY Dual Species Self-Contained Biological Indicators, Model/Catalog Number S3061. The affected products were distributed worldwide and nationwide in the United States. The recall involves specific lot numbers with expiration dates ranging from August 2026 to March 2027.
The recall was initiated because the Geobacillus stearothermophilus spore population in the affected products may fall below the minimum shelf life specification. When used to monitor steam sterilization cycles, this defect creates a potential hazard where the biological indicator may show no growth, incorrectly indicating that the steam cycle was effective even if the intended spore reduction was not achieved.
Healthcare facilities and other users of these biological indicators should stop using the affected products and contact Steris Corporation for instructions on return or replacement. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
- Manufacturer
- Steris Corporation
- Affected units
- 2,205
Distribution
Distributed nationwide across the United States.
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