Recall Ledger

VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006 recall (Steris Corporation)

Medical deviceClass IIOngoing

Summary: Steris Corporation is recalling VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006. Reason: 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 is being recalled

VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006

Why

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

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide - US Nationwide distribution.

How to tell if yours is affected

UDI: 10724995220324 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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-0070-2027
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedAugust 31, 2026
ReportedOctober 14, 2026
CompanySteris Corporation
Company locationMentor, OH, United States
Initiated byVoluntary: Firm initiated
Quantity266

More recalls from Steris Corporation · all medical device recalls · recalls from August 2026

Official FDA record