VERIFYRecalls & reported problems across all models

We found 11 models of VERIFY by Steris Corporation in the FDA's device registry (GUDID). Together they are named in 15 adverse event reports in the FDA's MAUDE database, received between May 1, 2023 and Feb 13, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 reports).

12 FDA recall records name at least one of these models by its device identifier, 12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

VERIFY recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-0075-2027 · 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-0074-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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 ↗

4. 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 ↗

5. 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-0071-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. 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-0070-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. Jan 9, 2024Open, Classified

   Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

   Z-1313-2024 · Root cause: Storage · Recall details · FDA record ↗

8. Dec 12, 2022Open, 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-0781-2023 · Root cause: Employee error · Recall details · FDA record ↗

9. Dec 12, 2022Open, 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-0780-2023 · Root cause: Employee error · Recall details · FDA record ↗

10. Dec 12, 2022Open, 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 ↗

11. Dec 12, 2022Open, 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 ↗

12. May 25, 2022Open, Classified

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

    Z-1793-2022 · Root cause: Environmental control · names 2 of these models · Recall details · FDA record ↗

Most reported VERIFY problems

VERIFY models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VERIFY Dual Species

  Indicator, biological sterilization process
  4 recalls1 report
• VERIFY S3069

  Indicator, biological sterilization process
  3 recalls0 reports
• VERIFY LCB035

  Indicator, physical/chemical sterilization process
  1 recall0 reports
• VERIFY S3065

  Indicator, biological sterilization process
  1 recall0 reports
• VERIFY LCC101

  ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
  1 recall0 reports
• VERIFY S3065

  Indicator, biological sterilization process
  1 recall0 reports
• VERIFY LCB006

  Indicator, biological sterilization process
  1 recall0 reports
• VERIFY LCB007

  Indicator, biological sterilization process
  1 recall0 reports
• VERIFY STEAM Integrating

  Indicator, physical/chemical sterilization process
  8 reports
• VERIFY STEAM Integrating

  Indicator, physical/chemical sterilization process
  5 reports
• VERIFY PCC071

  Indicator, physical/chemical sterilization process
  1 report

Recent VERIFY adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Component Missing

  THE USER FACILITY REPORTED VIA MEDWATCH #(B)(4) THAT MULTIPLE VERIFY STEAM INTEGRATING INDICATORS FAILED TO TURN DUE TO NOT HAVING THE SOLUTION IN THE INDICATOR FOR IT TO CHANGE PROPERLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338230 ↗
• 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 ↗
• MalfunctionJul 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA MEDWATCH: MW5171758 THAT THEIR VERIFY STEAM INTEGRATING INDICATORS ARE GIVING "INCONSISTENT RESULTS." NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669035 ↗
• MalfunctionJun 11, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR VERIFY STEAM INTEGRATING INDICATOR LEAKED RESULTING IN A PROCEDURE DELAY AS THE INSTRUMENTS HAD TO BE REPROCESSED PRIOR TO USE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186817 ↗
• MalfunctionJan 5, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR VERIFY STEAM INTEGRATING INDICATOR LEAKED IN THE INSTRUMENT SET AFTER PROCESSING. USER FACILITY PERSONNEL WERE NOT ABLE TO UTILIZE THE INSTRUMENT SET SUBSEQUENTLY CAUSING A PROCEDURE DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076036 ↗
• MalfunctionDec 12, 2024Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED VIA A VIGILANCE REPORT TO THE ITALIAN MINISTRY OF HEALTH THAT THEIR INDICATOR TAPE WAS DETACHING FROM THE STERILE BARRIER SYSTEM DURING THE STERILIZATION PHASE AND THE TAPE DID NOT CHANGE COMPLETELY. THE USER FACILITY REPORTED THAT THE DEVICES WERE REPROCESSED PRIOR TO USE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919922 ↗
• MalfunctionNov 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH REPORT (MW5159615) THAT THERE WAS NO DYE IN THE INDICATOR TO DETECT IF IT PASSED OR FAILED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20686151 ↗
• MalfunctionJul 3, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEIR VERIFY STEAM INTEGRATING INDICATORS HAD LEAKED INSIDE TWO INSTRUMENT CONTAINERS AFTER PROCESSING. THE LEAK WAS IDENTIFIED WHEN THE CONTAINERS WERE OPENED IN THE OR AND THE CONTAINERS WERE SENT FOR REPROCESSING RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669167 ↗
• MalfunctionApr 25, 2024Improper Chemical Reaction; Improper Chemical Reaction

  THE USER FACILITY REPORTED THAT FOUR OF THEIR VERIFY STEAM INTEGRATING INDICATORS DID NOT COMPLETELY ENTER THE ACCEPTANCE WINDOW FOLLOWING COMPLETED CYCLES RESULTING IN THE INSTRUMENTS HAVING TO BE REPROCESSED. THE FACILITY REPORTED PROCEDURE DELAYS OCCURRED AS A RESULT. THE PROCEDURES WERE COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19184733 ↗
• MalfunctionMar 28, 2024Leak/Splash; Insufficient Device Problem Information; Leak/Splash; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT THEIR VERIFY STEAM INTEGRATING INDICATOR LEAKED IN THE STERILIZED SET RESULTING IN A PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18993843 ↗
• MalfunctionJan 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT THEIR VERIFY STEAM INTEGRATING INDICATOR DID NOT "CHANGE IN COLOR" SUBSEQUENTLY RESULTING IN A PROCEDURE DELAY TO OCCUR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18505597 ↗
• MalfunctionDec 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT THE INDICATOR LEAKED BLUE INK INTO THEIR INSTRUMENT TRAY DURING A STERILIZATION CYCLE. A PROCEDURE DELAY WAS REPORTED AS THE INSTRUMENTS WERE REPROCESSED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332609 ↗
• MalfunctionNov 21, 2023Illegible Information; Illegible Information

  THE USER FACILITY REPORTED THAT THE VERIFY STEAM INTEGRATING INDICATOR HAD NO PAPER IN IT AFTER PROCESSING. USER FACILITY PERSONNEL WERE NOT ABLE TO USE THE INSTRUMENTS FROM THE TRAY SUBSEQUENTLY CAUSING A PROCEDURE DELAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18188202 ↗
• MalfunctionAug 24, 2023Improper Chemical Reaction; Improper Chemical Reaction

  THE USER FACILITY REPORTED MEDWATCH (B)(4) THAT THE EXTERNAL INDICATOR FOR THE STERILE TRAY CHANGED COLOR INDICATING STERILIZATION, HOWEVER THE INTERNAL STEAM INDICATOR COLOR DID NOT REACH THE END OF THE WINDOW. THE BLUE COLOR STOPPED IN THE MIDDLE OF THE WINDOW. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611088 ↗
• MalfunctionMay 1, 2023Improper Chemical Reaction; Improper Chemical Reaction

  THE USER FACILITY REPORTED THAT THE CHEMICAL WITHIN THEIR VERIFY STEAM INTEGRATING INDICATORS DID NOT COMPLETELY ENTER THE ACCEPTANCE WINDOW FOLLOWING COMPLETED CYCLES RESULTING IN PROCEDURE DELAYS. THE PROCEDURES WERE COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845408 ↗

Other Steris Corporation products

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• Celerity5 models · 10 reports · 1 recall