andorate® Disposable Endoscope Valves Set GAR004Recalls & reported problems
GA Health Company Limited · Class 2
All models of andorate Disposable Endoscope Valves Set (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04897106950225), received between Sep 25, 2020 and Sep 25, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- 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 problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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- OrcaPod™ SUV-629Boston Scientific Corporation · Endoscope channel accessory112 reports
- BullDog 1203-72Diversatek Healthcare, Inc. · Endoscope Channel Accessory1 recall0 reports
- Ruhof Scope Valet Guardian 345SVVO4Ruhof Corporation · Endoscope Channel Accessory1 recall0 reports
- 3-piece valve kit (Suction, Air/Water and Biopsy Valves) EN10229GA Health Company Limited · Endoscope Channel Accessory1 recall0 reports
- AutoCap™ RX M00545100Boston Scientific Corporation · Endoscope channel accessory26 reports
- OrcaPod™ SUV-633Boston Scientific Corporation · Endoscope channel accessory24 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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