Z-0071-2027 Class II Ongoing
FDA device recall Z-0071-2027 was initiated by Steris Corporation on Aug 31, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 409.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 14, 2026
- Initiation Date
- Aug 31, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 409
Product Description
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
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 Pattern
Worldwide - US Nationwide distribution.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0071-2027
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026