Device recall
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
- Recall number
- Z-0073-2027
- Event id
- 99704
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Steris Corporation
- Report date
- Oct 14, 2026
- Posted
- Oct 2, 2026
- Initiated
- Aug 31, 2026
- Center classification date
- Oct 2, 2026
- Product code
- FRC
- Device type
- Indicator, Biological Sterilization Process
- 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
- Root cause
- Under Investigation by firm
- Quantity
- 2205
- Code info
- UDI: 50724995023824 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 270302: expiration date - 03/02/2027
- Distribution
- Worldwide - US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K083665
- Location
- Mentor, OH, United States