VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
Summary
The FDA issued a Class II for VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: by Steris Corporation. Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam steri.
Details
Source
Device Recall
External ID
Z-0072-2027
Action Date
2026-10-14
Status
Ongoing
Category
device
Product Description
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
Lot/Code Info: UDI: 10724995023833 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
Quantity Affected: 1185
Reason for Recall
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
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-31
Company
Mentor, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 220 device recalls issued in the same week, part of 502 device-related FDA actions this month.
Steris Corporation has 74 FDA actions in our database, including 35 recalls and 39 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Steris Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Steris Corporation have FDA actions?
Steris Corporation has 74 FDA actions in our database, including 35 recalls and 39 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0072-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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