VERIFY STEAM Integrating (REF PCC064)Recalls & reported problems
Steris Corporation · The VERIFY Steam Integrating Indicator four-inch strip is for use in a variety of cycles and incorporates three critical variables of steam sterilization: steam, time, and temperature. · Class 2
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10724995002098), received between May 1, 2023 and Jul 30, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Improper Chemical Reaction” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Improper Chemical Reaction3
- Insufficient Device Problem Information3
- Illegible Information1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗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 ↗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 ↗
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- Comply™ 12483m Company · Indicator, physical/chemical sterilization process1 recall0 reports
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- Integron® IT26-CTerragene S.A. · Indicator, Physical/Chemical Sterilization Process1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.