Welch Allyn, Inc. 901069Recalls & reported problems
Welch Allyn, Inc. · Welch Allyn Green Series LED Procedure Headlight; One White LED, 50 Lumens, 5,500° K; Rigid Headband; 120 V, 50-60 Hz AC, IEC Plug Type-B · 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 00732094072174), received between Feb 24, 2022 and Feb 24, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sparking” (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
- Sparking1
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.
MalfunctionFeb 24, 2022Sparking; Sparking
THE CUSTOMER REPORTED THE PROCEDURE HEADLIGHT SPARKED WHILE THE USER WAS WEARING THE DEVICE. THE PROCEDURE HEADLIGHT WAS PLUGGED INTO A BATTERY PACK WHEN VISIBLE SPARKS WERE NOTED ON THE OUTSIDE OF THE DEVICE. THERE WAS NO INJURY OR BURN TO THE USER OR PATIENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13594137 ↗
Other Light, headband, surgical devices
- Integra® Duo 90620USIntegra Lifesciences (Ireland) Limited · Light, headband, surgical33 reports
- Integra® Duo 90600Integra Lifesciences (Ireland) Limited · Light, headband, surgical10 reports
- Integra® Duo 90622Integra Lifesciences (Ireland) Limited · Light, headband, surgical2 reports
- Integra® 90500Integra Lifesciences Production Corporation · Light, headband, surgical1 report
- Welch Allyn, Inc. 901067Welch Allyn, Inc. · Light, headband, surgical1 report
- Integra® 90520USIntegra Lifesciences Production Corporation · Light, headband, surgical1 report
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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