Steris Biological Indicators Recalled for Inconsistent Spore Growth
Steris Corporation is recalling VERIFY Dual Species Self-Contained Biological Indicators because some units in lot 230613 fail to consistently promote spore growth, potentially masking failed sterilization cycles.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a risk-of-harm product where biological indicators are critical to verifying sterilization in medical and clinical settings. No illnesses or injuries have been reported. The hazard is a potential failure of sterilization verification, not an actual harm event.
Plain-English summary
Steris Corporation has recalled 857 boxes of VERIFY Dual Species Self-Contained Biological Indicators (Item Number S3061) distributed nationwide and to several foreign countries. These indicators are used in installation testing and routine monitoring of steam and ethylene oxide sterilization processes.
Biological indicators in lot 230613 were found to be inconsistent in promoting spore growth. While some units in the lot performed as designed, others failed to properly promote growth of Geobacillus stearothermophilus and Bacillus atrophaeus spores.
When a biological indicator fails to promote spore growth as designed, it may incorrectly show no growth and indicate that a sterilization cycle was effective even if it was not. This could allow medical devices or equipment to be used without proper sterilization verification, potentially compromising patient safety.
Facilities using this product should contact Steris Corporation for guidance on affected units or replacement stock. The FDA has assigned recall number Z-0779-2023 to this action.
The recalled product
- Product
- VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
- Manufacturer
- Steris Corporation
- Affected units
- 857
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 (2)
- UDI: 10724995023833
- 50724995023824 lot #230613
Distribution
Part of a larger recall action
This product is one of 4 recalled by Steris Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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