Official recall record
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-08-31
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10724995220300
- Brand on record
- Steris Corporation
- Product category
- Medical Device
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-10-23.
Record last checked against the registry on 2026-10-23.
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VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
All 10 official recall notices naming Steris Corporation on this site →
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