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VERIFY S3065 (UDI 10724995220300)Recalls & reported problems

Steris Corporation · The VERIFY Disposable Biological Steam Test Pack is a single use test pack designed for monitoring the effectiveness of common steam sterilizing processes, including 250 degrees F (121 degrees C) gravity cycles and 270 degrees F (132 C) prevacuum cycles. 20 Packs with 5 Controls. · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K854902); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Aug 31, 2026Open, Classified

    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

    Z-0074-2027 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K854902. One submission often covers many models, so check the product and lot details in each record.

  • Z-0070-2027 · Aug 31, 2026 · Open, Classified
    VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006
  • Z-0071-2027 · Aug 31, 2026 · Open, Classified
    VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
  • Z-0075-2027 · Aug 31, 2026 · Open, Classified
    VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
  • Z-1793-2022 · May 25, 2022 · Open, Classified
    a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY Verify SixCess Sterilization Flash Indica
  • Z-0605-2014 · Sep 10, 2013 · Terminated
    VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam st

Other Indicator, biological sterilization process devices

All Indicator, biological sterilization process devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.