VERIFY recallZ-0075-2027 · Steris Corporation · initiated Aug 31, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0075-2027
- Status
- Open, Classified
- Initiated by the company
- Aug 31, 2026
- Posted by the FDA
- Oct 2, 2026
- Recalling firm
- Steris Corporation
- Quantity
- 233
- Product code
- FRC
- FDA submissions
- K854902
- Distribution
- Worldwide - US Nationwide distribution.
Product description
VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
Code information (models, lots, serial numbers)
UDI:10724995023864 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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VERIFY S3069Steris Corporation · Indicator, biological sterilization process3 recalls0 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K854902 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- VERIFY S3065Steris Corporation · Indicator, biological sterilization process1 recall0 reports
- VERIFY LCB006Steris Corporation · Indicator, biological sterilization process1 recall0 reports
- VERIFY LCB007Steris Corporation · Indicator, biological sterilization process1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99704).
- Z-0070-2027 · Open, ClassifiedVERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006
- Z-0071-2027 · Open, ClassifiedVERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
- Z-0072-2027 · Open, ClassifiedVERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
- Z-0073-2027 · Open, ClassifiedVERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
- Z-0074-2027 · Open, ClassifiedVERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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