Steris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
Steris Corporation is recalling VERIFY Biological Steam Test Packs because the spore population may fall below specifications, potentially causing false-negative steam 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a potential hazard where false-negative sterilization results could occur due to low spore populations. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Steris Corporation is recalling 233 units of VERIFY Biological Steam Test Packs, Model/Catalog Number S3069. The affected products were distributed worldwide and nationwide in the United States. The recall involves specific lot numbers with expiration dates ranging from August 2026 to January 2027.
The recall was initiated because the Geobacillus stearothermophilus spore population in the affected products may fall below the minimum shelf life specification. This defect creates a potential hazard where the biological indicator may show no growth, incorrectly indicating that a steam sterilization cycle was effective when it may not have achieved the intended spore reduction.
The source text does not report any illnesses, injuries, or deaths associated with this recall. Users of these test packs should stop using the affected units and contact Steris Corporation for further instructions.
The recalled product
- Product
- VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
- Manufacturer
- Steris Corporation
- Affected units
- 233
Distribution
Distributed nationwide across the United States.
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