The Recall Desk
HighFDA (Devices)·Z-0778-2023·Announced 2023-01-11

Steris Biological Indicator Lot May Fail to Detect Inadequate Sterilization

Steris Corporation is recalling 338 boxes of VERIFY Dual Species Biological Indicators (Lot #230613) because some units fail to promote spore growth as intended, risking false-negative sterilization test results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a critical sterilization control device where some units fail to function as intended, creating the risk of undetected inadequate sterilization. No illnesses or injuries have been reported to date, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Steris Corporation is recalling 338 boxes of VERIFY Dual Species Self-Contained Biological Indicators (Item S3060, Lot #230613) intended for monitoring steam and ethylene oxide sterilization processes in healthcare and industrial settings.

The biological indicators in the affected lot show inconsistent performance. Some units in the lot failed to promote growth of G. stearothermophilus and B. atrophaeus spores as designed, while others functioned correctly.

When a biological indicator fails to show growth despite an inadequate sterilization cycle, the result is a false negative—incorrectly suggesting the sterilization was successful when it was not. This could lead healthcare facilities to use inadequately sterilized medical equipment and instruments in patient care.

Facilities and manufacturers using this product should discontinue use immediately and contact Steris Corporation. The product was distributed nationwide and internationally across multiple countries. Users should verify their sterilization processes through alternative testing methods or replacement biological indicators.

The recalled product

Product
VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Manufacturer
Steris Corporation
Category
Medical Device — Sterilization Monitoring
Hazard
  • false-negative
  • sterilization-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI: 10724995023833 lot #230613

Distribution

Distributed nationwide across the United States.

Related recalls

Same category