Natus 8-62-45300Recalls & reported problems
Natus Medical Denmark ApS · Aurical Freefit without charger (Japan only) · 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 05713315009051), received between Mar 30, 2022 and Mar 30, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Battery Problem” (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
- Battery 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.
MalfunctionMar 30, 2022Battery Problem; Battery Problem
UNIT SHUTS OFF INTERMITTENTLY. THE CUSTOMER REPORTS, SOMETIMES IT HELPS TO REMOVE BATTERY, BUT NOT ALWAYS. SOMETIMES IT SHOWS NO CHARGING STATUS (LED DARK) AND THE BATTERY GETS WARM. NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13949909 ↗
Other Calibrator, Hearing Aid / Earphone And Analysis Systems devices
- GN Otometrics A/S Aurical FreeFit, Complete SolutionNatus Medical Denmark ApS · Calibrator, Hearing Aid / Earphone And Analysis Systems1 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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