Steris VERIFY Dual Species Biological Indicator recalled for unreliable spore population
What this means
Steris Corporation is recalling certain lots of VERIFY Dual Species Self-Contained Biological Indicator (Model S3060) because the spore population may be lower than specified. When these indicators are used to monitor steam sterilization cycles, they may show no growth even if the sterilization cycle did not work properly, creating a risk that contaminated medical equipment could be released for patient use.
- If you have affected lot numbers 260810, 260810A, 261106, 270116, or 270302, stop using them.
- Contact Steris Corporation for instructions on returning the product or obtaining replacement indicators.
- Review any recent sterilization cycles run with affected lots to ensure equipment safety.
The agency's original wording
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0072-2027More Steris recalls
- FDA-Device2026-10-14Steris VERIFY Biological Steam Test Pack recalled for inadequate spore population
- FDA-Device2026-10-14Steris HexaVue Focus Integration System software issue may print incorrect patient information
- FDA-Device2026-10-14Steris VERIFY Biological Integrator Challenge Pack recalled for insufficient spore population
- FDA-Device2026-10-14Steris VERIFY Dual Species Biological Indicator recalled for insufficient spore population
- FDA-Device2026-10-14Steris VERIFY Biological Integrator Challenge Pack recalled for inadequate spore population
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