Steris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
Steris Corporation is recalling 217 VERIFY Biological Steam Test Packs because the spore population may fall below specifications, 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 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 the biological indicator may falsely indicate effective sterilization, but the source does not report any illnesses, injuries, or deaths.
Plain-English summary
Steris Corporation is recalling 217 units of the VERIFY Biological Steam Test Pack, Model/Catalog Number S3065. 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. When used to monitor steam sterilization cycles, this defect presents a potential hazard where the biological indicator may show no growth, incorrectly indicating that the steam cycle was effective even if the intended spore reduction was not achieved.
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: S3065
- Manufacturer
- Steris Corporation
- Affected units
- 217
Distribution
Distributed nationwide across the United States.
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