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U.S. Department of Health and Human Services

Class 2 Device Recall VERIFY Biological/Integrator Challenge Pack

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 Class 2 Device Recall VERIFY Biological/Integrator Challenge Packsee related information
Date Initiated by FirmAugust 31, 2026
Date PostedOctober 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0071-2027
Recall Event ID 99704
510(K)NumberK854902 
Product Classification Indicator, biological sterilization process - Product Code FRC
ProductVERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
Code Information UDI: 10724995220331 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
FEI Number 1527821
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information ContactMichelle LaVan
440-2597417
Manufacturer 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
FDA Determined
Cause 2		Under Investigation by firm
ActionFirm began notifying customers on August 31, 2026 via URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to destroy any affected product on hand. The firm will replace any product still within its shelf life.
Quantity in Commerce409
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FRC
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