Steris VERIFY Biological Integrator Challenge Pack recalled for inadequate spore population
What this means
Some Steris VERIFY Biological/Integrator Challenge Packs (Model LCB006) may contain fewer sterilization-testing spores than specified. This could cause the test to show a successful steam sterilization cycle when the cycle did not actually kill enough microorganisms to be safe.
- Check if you have lots 260810, 260810A, 261106, or 270116 with expiration dates between August 2026 and January 2027.
- Contact Steris Corporation or your supplier for instructions on affected units and replacements.
- Do not use affected packs to validate steam sterilization cycles until you hear from Steris.
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-0070-2027More 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 Dual Species Biological Indicator recalled for insufficient spore population
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