Steris VERIFY Biological Indicator Recall Due to Spore Population Concerns
Steris is recalling VERIFY Dual Species Self-Contained Biological Indicators because spore populations may fall below specifications, potentially leading to 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 successful sterilization, but the source does not report any illnesses, injuries, or deaths.
Plain-English summary
Steris Corporation is recalling 1,185 units of VERIFY Dual Species Self-Contained Biological Indicators, Model/Catalog Number S3060. The recall covers specific lot numbers with expiration dates ranging from August 2026 to March 2027. The products were distributed worldwide and nationwide in the United States.
The recall is issued 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.
Healthcare facilities and other users of these biological indicators should stop using the affected units and contact Steris Corporation for further instructions on return or replacement.
The recalled product
- Product
- VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
- Manufacturer
- Steris Corporation
- Affected units
- 1,185
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Steris Corporation
See all →- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
Same hazard · false negative result
See all →- ModerateDRG Sperm Ab ELISA Recalled for Potential False Negative Results
FDA (Devices) · 2026-10-14
- HighBioFire Respiratory Panel 2.1 Recalled for Increased False Negative Results
FDA (Devices) · 2026-08-19
- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
Similar recalls
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- ModerateSteris Recalls Verify Dual Species Biological Indicators Due to Spore Count Defect
FDA (Devices) · 2014-01-08
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris Biological Indicators Recalled for Inconsistent Spore Growth
FDA (Devices) · 2023-01-11
- HighSteris Biological Indicator Lot May Fail to Detect Inadequate Sterilization
FDA (Devices) · 2023-01-11