Steris VERIFY Biological Steam Test Pack recalled for inadequate spore population
What this means
Steris Corporation's VERIFY Biological Steam Test Pack (Model S3069) may contain fewer bacterial spores than specified. This could cause the test to incorrectly show that a steam sterilization cycle worked properly, even when it did not kill enough microorganisms to ensure safe sterilization of medical instruments.
- Check if you have affected lot numbers 260810, 260810A, 261106, or 270116 with expiration dates through January 2027.
- Stop using affected test packs immediately.
- Contact Steris Corporation or your supplier for instructions on replacement or disposal.
- Review records of any sterilization cycles validated with these packs and consider re-sterilizing affected instruments if needed.
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-0075-2027More Steris recalls
- 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
- FDA-Device2026-10-14Steris VERIFY Biological Integrator Challenge Pack recalled for inadequate spore population
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