The Recall Desk
HighFDA (Devices)·Z-0780-2023·Announced 2023-01-11

VERIFY Steam Test Pack Biological Indicators May Fail to Detect Sterilization Failure

Steris is recalling VERIFY Steam Test Packs because biological indicators in affected lots may fail to correctly monitor steam and ethylene oxide sterilization, potentially allowing failed sterilization to go undetected.

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 involving a critical sterilization control device with a theoretical hazard of undetected sterilization failure. The source text explicitly states no illnesses or injuries have been reported; per the rubric, theoretical hazards without reported harm score at High (3).

Plain-English summary

Steris Corporation is recalling VERIFY Steam Test Packs (Item Number S3065) distributed nationwide and internationally. The affected product includes 60 boxes with lot number 230613 and UDI 10724995023840. These packs contain biological indicators intended for installation testing and routine monitoring of steam and ethylene oxide sterilization processes.

The biological indicators in the affected lot were inconsistent in promoting growth of Geobacillus stearothermophilus and Bacillus atrophaeus spores required for testing. Some indicators in the lot performed as intended while others did not. This inconsistency affects the reliability of these test packs.

When used to monitor sterilization cycles, a biological indicator that shows no growth is interpreted as indicating the sterilization process was effective. However, if an indicator fails to show growth due to a product defect rather than because sterilization was successful, it may incorrectly indicate an effective cycle when sterilization actually failed. The potential hazard is that medical devices may be released as sterilized when they have not been properly sterilized.

The recalled product

Product
VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 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
  • sterilization-failure-detection
  • device-malfunction
  • false-negative-test-result

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: 10724995023840 lot #230613

Distribution

Distributed nationwide across the United States.

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