Integron® IT26-C (UDI 07798164679622)Recalls & reported problems
Terragene S.A. · Moving front chemical integrator for steam sterilization processes. · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07798164679622), received between Jan 8, 2024 and Sep 10, 2024 — classified as 5 malfunctions.
1 FDA recall record name this device's identifier, 1 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Dec 7, 2023Open, Classified
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
Z-0836-2024 · Root cause: Labeling False and Misleading · FDA record ↗
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available5
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.
MalfunctionSep 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
USER FACILITY INFORMED THAT THE INTEGRON IT26-C BURST AFTER A COMPLETE STERILIZATION CYCLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20180306 ↗MalfunctionJun 30, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A USER FACILITY INFORMED THAT THE INTEGRON IT26-C CI HAS LEAKAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19640729 ↗MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT TWO STRIPS THAT DIDN'T REACT TO THE STEAM. THE USE OF THE PRODUCT WAS DISCONTINUATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18476826 ↗MalfunctionJan 8, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
USER REPORTED THE CHEMICAL INTEGRATOR WAS NOT REACTING TO THE STERILIZATION CYCLE, AS IT WAS NOT SHOWING CHANGE OF COLOR IN THE BAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18465663 ↗MalfunctionJan 8, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A CHEMICAL INTEGRATOR SHOWED INK LEAKING AFTER THE STERILIZATION CYCLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18464257 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.