The Recall Desk
HighFDA (Devices)·Z-0781-2023·Announced 2023-01-11

Steris VERIFY Steam Test Pack biological indicators show inconsistent performance

Steris Corporation is recalling VERIFY Steam Test Pack biological indicators (lot #230613) due to inconsistent performance in promoting spore growth. When used to monitor sterilization, some indicators may not show growth even if the sterilization cycle was ineffective, creating false assurance of sterility.

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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical but fits the rubric criterion for risk-of-harm products where injury has not yet been reported. Biological indicators that produce false negatives could allow undetected sterilization failures, making this a high-risk scenario for patient safety despite the absence of actual adverse events.

Plain-English summary

Steris Corporation is recalling VERIFY Steam Test Pack (Item Number S3069) biological indicators used in sterilization process monitoring. The product comes in boxes containing 20 tests and 20 controls.

The biological indicators in affected lot #230613 showed inconsistent performance in promoting growth of spores (Geobacillus stearothermophilus and Bacillus atrophaeus). While some indicators functioned correctly, others did not perform as intended. This inconsistency affects the reliability of sterilization monitoring.

When used to validate steam and ethylene oxide sterilization cycles, affected biological indicators may fail to show growth even if a sterilization cycle was not actually effective. This creates a false negative result—a healthcare facility could believe a sterilization process was successful when it was not, potentially compromising product sterility and patient safety.

Steris has distributed this product nationwide and to international locations. Healthcare facilities using affected lot #230613 should identify and quarantine any remaining product and contact Steris Corporation regarding replacement or return. Facilities should consider alternative validation methods for any sterilization cycles that may have been monitored using affected test packs.

The recalled product

Product
VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 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
  • manufacturing-defect
  • sterilization-validation

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: 10724995023864 lot #230613

Distribution

Distributed nationwide across the United States.

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