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Steris Corporation: VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061

Medical DevicesSource: FDA (device) · Date: 2026-10-14

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Steris Corporation
Product
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Reason / hazard
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution.
Recall initiated
2026-08-31
Code info
UDI: 50724995023824 Lot numbers: 260810: expiration date - 08/10/2026 260810A: expiration date - 08/10/2026 261106: expiration date - 11/06/2026 270116: expiration date - 01/16/2027 270302: expiration date - 03/02/2027
Product quantity
2205
Voluntary mandated
Voluntary: Firm initiated
City
Mentor
State
OH
Country
United States
Event id
99704
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