Steris VERIFY Biological Integrator Challenge Pack recalled for insufficient spore population
What this means
Steris Corporation has recalled certain VERIFY Biological/Integrator Challenge Pack units (model LCB007) because the spore population may be lower than required. These packs are used to verify that steam sterilization equipment is working properly. If spore levels are too low, the test may falsely show that sterilization was successful when it was not.
- Check if you have VERIFY Challenge Pack model LCB007 with lot numbers 260810, 260810A, 261106, or 270116
- Do not use affected units to validate steam sterilization cycles
- Contact Steris Corporation for replacement units or further instructions
- Review any recent sterilization cycles performed with recalled units to ensure equipment is functioning correctly
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-0071-2027More 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 Dual Species Biological Indicator recalled for unreliable 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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