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
Recalls naming this device
- 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 ↗
- 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 ↗
- 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 ↗
- 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
- VERIFY S3069Steris Corporation · Indicator, biological sterilization process3 recalls0 reports
- Cyclesure 14324Advanced Sterilization Products Services Inc. · Indicator, biological sterilization process74 reports
- Celerity LCB044Steris Corporation · Indicator, biological sterilization process1 recall4 reports
- Celerity LCB053Steris Corporation · Indicator, biological sterilization process1 recall2 reports
- Bionova® (K)PCD222-CTerragene S.A. · Indicator, Biological Sterilization Process1 recall1 report
- Celerity LCB049Steris Corporation · Indicator, biological sterilization process1 recall1 report
- VERIFY LCB007Steris Corporation · Indicator, biological sterilization process1 recall0 reports
- VERIFY S3065Steris Corporation · Indicator, biological sterilization process1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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