VERIFY STEAM Integrating (REF PCC065)Recalls & reported problems
Steris Corporation · The VERIFY Steam Integrating Indicator 5CM 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10724995002104), received between Jan 12, 2024 and Feb 13, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash3
- Insufficient Device Problem Information2
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, 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 ↗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 ↗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 ↗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 ↗
Other Indicator, physical/chemical sterilization process devices
- Integron® IT26-CTerragene S.A. · Indicator, Physical/Chemical Sterilization Process1 recall5 reports
- BENCO 5726-583Benco Dental Supply CO. · Indicator, Physical/Chemical Sterilization Process1 recall0 reports
- 3M™ Attest™ 1243A3m Company · Indicator, physical/chemical sterilization process1 recall0 reports
- 3M™ Attest™ 1243B3m Company · Indicator, physical/chemical sterilization process1 recall0 reports
- DH Nyclave Indicator Labels 116312Young Dental Manufacturing I, LLC · Indicator, Physical/Chemical Sterilization Process1 recall0 reports
- Comply™ 12483m Company · Indicator, physical/chemical sterilization process1 recall0 reports
- Comply™ 12483m Company · Indicator, physical/chemical sterilization process1 recall0 reports
- 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.