Steris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
Steris is recalling VERIFY Biological/Integrator Challenge Packs because the spore population may be too low, potentially causing false results in steam sterilization monitoring.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a potential hazard where the product may fail to detect ineffective steam sterilization cycles, but the source does not report any illnesses, injuries, or deaths.
Plain-English summary
Steris Corporation is recalling 409 units of the VERIFY Biological/Integrator Challenge Pack, Model/Catalog Number LCB007. 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 January 2027.
The recall was issued because the Geobacillus stearothermophilus spore population in the affected products may fall below the minimum shelf life specification. When these biological indicators are used to monitor steam sterilization cycles, this defect creates a potential hazard where the indicator may show no growth, incorrectly indicating that the steam cycle was effective even if it did not achieve the intended spore reduction.
The source text does not report any illnesses, injuries, or deaths associated with this recall. Users of these products should stop using the affected lots and contact Steris Corporation for further instructions or a replacement.
The recalled product
- Product
- VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
- Manufacturer
- Steris Corporation
- Affected units
- 409
Distribution
Distributed nationwide across the United States.
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