andorate Disposable Endoscope Valves SetRecalls & reported problems across all models
GA Health Company Limited · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of andorate Disposable Endoscope Valves Set by GA Health Company Limited in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Sep 25, 2020 and Nov 6, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
andorate Disposable Endoscope Valves Set 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.
- Nov 3, 2020Class IITerminated
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Z-0643-2021 · Root cause: Process control · Recall details · FDA record ↗
Most reported andorate Disposable Endoscope Valves Set problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
andorate Disposable Endoscope Valves Set models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- andorate® Disposable Endoscope Valves Set GAR004Endoscope Channel Accessory1 recall1 report
- andorate® Disposable Endoscope Valves Set GAR004CEndoscopic Irrigation/Suction System1 report
Recent andorate Disposable Endoscope Valves Set adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2020Break; Break
SUCTION VALVE REPORTED FELL APART AND DID NOT WORK FROM 2 LOTS. THE EVENTS OCCURRED OUTSIDE THE US. THERE IS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10802110 ↗MalfunctionSep 25, 2020Break; Break
THE SUCTION BUTTON IS REPORTED STICKY AND/OR BROKEN DURING OR AFTER THE PROCEDURE FROM THREE LOTS. THE EVENTS OCCURRED OUTSIDE THE US AND THE DEVICE IS NOT RETURNED FOR ANALYSIS. THERE IS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10586521 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page