Steris VERIFY Biological/Integrator Challenge Pack Recall for Sterilization Monitoring Failure
Steris Corporation is recalling VERIFY Biological/Integrator Challenge Packs because the spore population may be too low to accurately monitor steam sterilization cycles.
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 hazard where the product may falsely indicate successful sterilization, potentially leading to exposure to non-sterile medical devices. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Steris Corporation is recalling 266 units of the VERIFY Biological/Integrator Challenge Pack, Model/Catalog Number LCB006. The affected products were distributed worldwide and across the United States. The specific lot numbers and expiration dates are 260810 (08/10/2026), 260810A (08/10/2026), 261106 (11/06/2026), and 270116 (01/16/2027).
The recall is due to a potential defect where the Geobacillus stearothermophilus spore population in the products may fall below the minimum shelf-life specification. When used to monitor steam sterilization cycles, this defect could cause the biological indicator to show no growth, falsely indicating that the steam cycle was effective even if it did not achieve the intended spore reduction.
The source text does not specify instructions for consumers or healthcare facilities on how to handle the recalled items. Users of these products should contact Steris Corporation for further guidance.
The recalled product
- Product
- VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006
- Manufacturer
- Steris Corporation
- Affected units
- 266
Distribution
Distributed nationwide across the United States.
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