TemporaryFDAOngoing
Can cause harm that is usually temporary.
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Check the device or its packaging for
UDI: 10724995220300 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
- Why
- 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
- Distributed
- Worldwide - US Nationwide distribution.
- Company
- Steris Corporation
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0074-2027 · retrieved 2 October 2026
Read the official notice