Official recall notice

FDA DeviceClass IINotable

VERIFY Dual Species Self-Contained Biological Recall (Oct 2026)

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

Recall date
2026-10-14
FDA class
Class II

Why it was recalled

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

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Product description

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

Affected products

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

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