Recall Z-0073-2027 ยท FRC Indicator, Biological Sterilization Process
Steris Corporation
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
| Date | Oct 2, 2026 (initiated Aug 31, 2026) |
| Status | Open, Classified |
| 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 |
| Action | Firm began notifying customers on August 31, 2026 via URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to destroy any affected product on hand. The firm will replace any product still within its shelf life. |
| Quantity | 2205 |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083665 | VERIFY SCBI 275F 3-10 STERIS Corporation, Sep 1, 2009 |