Recall Z-0074-2027— Steris Corporation
Class II · Ongoing
Class II FDA medical device recall by Steris Corporation, initiated 2026-08-31. It names one FDA 510(k) clearance: K854902. Product: VERIFY Biological Steam Test Pack Model/Catalog Number: S3065. Reason: 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.
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-31
- Firm location
- Mentor, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.