Recall archive / FDA device enforcement
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP — FDA record Z-0403-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 26, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
- Reason
- Affected lots of product may experience technical distortions to a greater extent than expected.
- Classification
- Class II
- Recalling firm
- PATH
- Quantity
- 23 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0403-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 04260223143298; Serial Numbers: 260446-260468 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US States: FL, MO, OH, WI
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 6, 2023
- Recall initiation date
- Sep 26, 2023
- Center classification date
- Nov 24, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.