Steris VERIFY Biological Steam Test Packs and Biological Indicators
Verify Biological/Integrator Challenge Pack may have spore population below specification, potentially showing no growth in steam sterilization monitoring.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Steris Corporation recalled certain Verify Biological/Integrator Challenge Pack and Verify Dual Species Self-Contained Biological Indicator and Verify Biological Steam Test Pack products because the Geobacillus stearothermophilus spore population may fall below minimum shelf life specification.
When used to monitor steam sterilization cycles, the biological indicator may show no growth, indicating the steam cycle was effective even if it did not achieve the intended spore reduction. The recall began August 31, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match your product and all the details in one listed combination.
VERIFY Biological Steam Test Pack Model/
- Lot
- 260810
- UDI-DI
- 10724995220300
- Catalog code
- S3065
- UDI-DI
- 10724995023864
- Catalog code
- S3069
VERIFY Biological/Integrator Challenge Pack Model/
- Lot
- 260810
- UDI-DI
- 10724995220324
- Catalog code
- LCB006
- UDI-DI
- 10724995220331
- Catalog code
- LCB007
VERIFY Dual Species Self-Contained Biological Indicator Model/
- Lot
- 260810
- UDI-DI
- 50724995023824
- Catalog code
- S3061
- UDI-DI
- 10724995023833
- Catalog code
- S3060
Details
- Company began the recall
- Event ID
- 99704
- Company
- Steris Corporation
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
