Steris Recalls Verify Dual Species Biological Indicators Due to Spore Count Defect
Steris is recalling Verify Dual Species Self-Contained Biological Indicators because the spore count is lower than labeled, potentially causing false sterilization results.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential for false sterilization results rather than a direct physical injury, fitting the criteria for a moderate severity score.
Plain-English summary
Steris Corporation is recalling 1,238 boxes of Verify Dual Species Self-Contained Biological Indicators, Lot #131004. The affected models are S3060, S3061, S3065, S3069, LCB006, and LCB007. These products are intended for installation testing and routine monitoring of steam and ethylene oxide sterilization processes.
The recall was initiated because the population of G. stearothermophilus spores used to monitor steam sterilization cycles does not meet specifications. The spore count on the affected product is lower than the labeled minimum, which may cause the product to incorrectly indicate that a 5-log spore kill was achieved.
The affected units were distributed worldwide, including nationwide in the United States and in Bahrain, Canada, Colombia, Germany, Italy, Malaysia, the Philippines, Romania, Spain, and the Netherlands. Users should check their inventory for Lot #131004 and contact Steris Corporation for further instructions.
The recalled product
- Product
- VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.
- Manufacturer
- Steris Corporation
- Affected units
- 1,238
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 (5)
- Lot #131004 Model #'s: S3060
- S3061
- S3065
- S3069
- LCB006 & LCB007.
Distribution
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