FDAClass IIRecall started August 31, 2026

VERIFY Dual Species Self-Contained Biological Indicator (S3061) Recall

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

What is the FDA recall status?

The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was VERIFY Dual Species Self-Contained Indicator recalled?

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

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Which lot codes, UPCs or models are affected?

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

Agency record number
Z-0073-2027
Product
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Recalling firm
Steris Corporation
Quantity
2205
Distribution
Worldwide - US Nationwide distribution.
Recall started
August 31, 2026
Report date
October 14, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls