Recall Z-0071-2027
- Recall number
- Z-0071-2027
- Event number
- 99704
- Firm
- Steris Corporation
- Firm FEI
- 1527821
- Product code
- FRC
- Status
- Open, Classified
- Initiated
- 2026-08-31
- Posted
- 2026-10-02
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K854902, K191021, K113221, K963841, K240717, K223715, K895704, K111391, K173584, K891784, K926364, K190297, K844479, K172474, K971432, K140392, K031012, K771080, K771132, K855120, K140620, K101910, K200766, K032914, K930682, K250044, K971430, K073244, K122362, K812272
Product#
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
Reason for Recall#
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