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VERIFY Dual SpeciesRecalls & reported problems

Steris Corporation · The VERIFY Dual Species Self-Contained Biological Indicator is for use in installation testing and routine monitoring of steam sterilization processes employing dynamic air removal for prevacuum and SFPP or gravity preconditioning phases and ethylene oxide sterilization processes. · Class 2

All models of VERIFY (11)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
4

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10724995023833), received between Oct 30, 2025 and Oct 30, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

4 FDA recall records name this device's identifier, 4 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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-0073-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  2. 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-0072-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  3. Dec 12, 2022Class IIOpen, Classified

    Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.

    Z-0779-2023 · Root cause: Employee error · Recall details · FDA record ↗

  4. Dec 12, 2022Class IIOpen, Classified

    Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.

    Z-0778-2023 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Device problems

  • Insufficient Device Problem Information1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    STERIS WAS CONTACTED ON (B)(6) 2025 REGARDING AN ALLEGED INFECTION FOLLOWING A PATIENT PROCEDURE OCCURRING ON (B)(6) 2023. IT WAS REPORTED THAT THE VERIFY DUAL SPECIES SELF CONTAINED BIOLOGICAL INDICATOR AND VERIFY DISPOSABLE BIOLOGICAL STEAM TEST PACK WERE USED WITH THE STERILIZER AT THE USER FACILITY.

    Patient problems: Insufficient Information

    MAUDE report 23425170 ↗

Other Indicator, biological sterilization process devices

All Indicator, biological sterilization process devices →

Sources and updates

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