Steris Corporation: Indicator, Biological Sterilization Process
Recall Summary Steris Corporation is recalling VERIFY Biological Steam Test Pack (Model S3065) because the spore population may be below specification, which could cause the indicator to show false results during steam sterilization monitoring. If a steam sterilization cycle fails to work properly, the test pack might still indicate success, creating a safety risk for medical devices or equipment that weren't actually sterilized. The recall affects units distributed nationwide and worldwide.
- Recalling firm
- Steris Corporation
- Product
- VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
- 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
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-31
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ba747c24-21f3-4706-8ab6-86540fb59f86