andorate® Disposable Endoscope Valves Set GAR004CRecalls & 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
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04897106950232), received between Nov 6, 2020 and Nov 6, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
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.
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 ↗
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- BullDog® 1203-71Diversatek Healthcare, Inc. · Endoscopic Irrigation/Suction System1 recall0 reports
- ERBEFLO CleverCap® 20325-201Erbe Medical, LLC · Endoscopic Irrigation/Suction System1 recall0 reports
- 2-piece valve kit (Suction and Air/Water Valve) EN10229.2GA Health Company Limited · Endoscopic Irrigation/Suction System1 recall0 reports
- 4-piece valve kit(Suction, Air/Water, Biopsy Valves & Auxiliary Water Connector) EN10229.1GA Health Company Limited · Endoscopic Irrigation/Suction System1 recall0 reports
- ERBEFLO CleverCap® 20325-203Erbe Medical, LLC · Endoscopic Irrigation/Suction System1 recall0 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
- 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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