- Recalling firm
- Steris Corporation
- 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
- Affected products (lot / model / serial)
- UDI: 10724995220331 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027
- Units affected
- 409
- Distribution pattern
- Worldwide - US Nationwide distribution.
- Firm location
- Mentor, OH, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0071-2027
- Recall initiated
- August 31, 2026
- FDA classification date
- October 2, 2026
- FDA report date
- October 14, 2026
- FDA event ID
- 99704
- Last updated on HTM Vibe
- October 21, 2026
