SUCTION VALVE MAJ-1443Recalls & reported problems
Olympus Medical Systems Corp. · Class 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 04953170467325), received between Jan 12, 2026 and Jan 12, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Reprocessing Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K250949); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Device Reprocessing Problem1
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.
MalfunctionJan 12, 2026Device Reprocessing Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24045866 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K250949. One submission often covers many models, so check the product and lot details in each record.
- Z-1611-2026 · Feb 12, 2026 · Open, ClassifiedOlympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
- Z-1610-2026 · Feb 12, 2026 · Open, ClassifiedOlympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Other Endoscope Channel Accessory devices
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- Orca™ SUV-617Boston Scientific Corporation · Endoscope Channel Accessory1 recall64 reports
- OrcaPod™ SUV-629Boston Scientific Corporation · Endoscope channel accessory112 reports
- andorate® Disposable Endoscope Valves Set GAR004GA Health Company Limited · Endoscope Channel Accessory1 recall1 report
- 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
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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