Steris VERIFY Dual Species Biological Indicator recalled for insufficient spore population
What this means
Certain batches of Steris VERIFY Dual Species Self-Contained Biological Indicator (Model S3061) may contain fewer bacterial spores than specified. This could cause the indicator to show no growth during steam sterilization monitoring, falsely suggesting the sterilization cycle was effective when it may not have been.
- Check your biological indicators against the affected lot numbers (260810, 260810A, 261106, 270116, 270302) and expiration dates listed in the recall
- Do not use affected units to verify steam sterilization cycles
- Contact Steris Corporation for replacement units or further instructions
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-0073-2027More 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 unreliable spore population
- FDA-Device2026-10-14Steris VERIFY Biological Integrator Challenge Pack recalled for inadequate spore population
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