Steris VERIFY Biological Steam Test Pack recalled for low spore population
What this means
Steris Corporation's VERIFY Biological Steam Test Pack (Model S3065) may contain fewer bacterial spores than required. This could cause the test to incorrectly show that steam sterilization worked properly, even when it did not adequately kill harmful microorganisms on medical equipment.
- Check if you have lot numbers 260810, 260810A, 261106, or 270116 with the expiration dates shown
- Contact Steris Corporation for guidance on affected test packs
- Do not rely on test results from affected lots to confirm sterilization is complete
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-0074-2027More 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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