IntegronRecalls & reported problems across all models
Terragene S.A. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Integron model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 3 models of Integron by Terragene S.A. in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Jan 8, 2024 and Sep 10, 2024 — classified as 5 malfunctions.
1 FDA recall record name at least one of these models by its device 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. 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
Reports received per month, all models
Integron 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.
- 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 · names 3 of these models · Recall details · FDA record ↗
Most reported Integron problems
Device problems
- Appropriate Device Problem Term/Code Not Available5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Integron models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Integron® IT26-CIndicator, Physical/Chemical Sterilization Process1 recall5 reports
- Integron® IT26-CIndicator, Physical/Chemical Sterilization Process1 recall0 reports
- Integron® PCD26-CIndicator, Physical/Chemical Sterilization Process1 recall0 reports
Recent Integron adverse event reports
The 5 most recent reports across all models, 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 ↗
Other Terragene S.A. products
All Terragene S.A. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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