Welch Allyn, Inc. 901081Recalls & reported problems
Welch Allyn, Inc. · Welch Allyn 3.5 V Halogen HPX Ophthalmoscope Set with Coaxial Ophthalmoscope (#11720), Rechargeable 60-Minute Power Handle(s) -- C-C ell Convertible, Hard Storage Case; Nickel-Cadmium (#72300) Battery; IEC Plug Type-A · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00732094089417), received between Aug 26, 2020 and Aug 26, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Gas/Air Leak” (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
- Gas/Air Leak1
Patient problems
- Extubate1
- Unintended Extubation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2020Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S CUFF PRESSURE WAS FOUND TO BE 0. THE CUFF PRESSURE WAS CHECKED THREE TIMES A DAY BEFORE THAT, AND THERE HAD BEEN NO PROBLEM. WHEN THE AIR WAS INJECTED THE PRESSURE WAS INCREASED THE TEMPORARILY, BUT WAS SEEN GRADUALLY DECREASED. RE-INTUBATION REQUIRED.
Patient problems: Extubate; Unintended Extubation
MAUDE report 10457651 ↗
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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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