Medical device for hearing exams recalled for technical distortion issues
PATH is recalling AuDX PRO hearing examination devices because they may produce technical distortions greater than expected, which could affect diagnostic accuracy. The recall affects 23 units distributed in Florida, Missouri, Ohio, and Wisconsin.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The technical distortion hazard is a device performance issue without documented patient harm, consistent with Moderate severity per the rubric.
Plain-English summary
PATH is recalling the AuDX PRO, a mobile medical device used for hearing examinations (Model Number SOH100098, Part Number 100098-AUP). The recall involves 23 units with serial numbers 260446-260468 that were distributed in Florida, Missouri, Ohio, and Wisconsin.
The affected devices may experience technical distortions to a greater extent than expected. For a device used to conduct hearing examinations, such distortions could compromise the accuracy of test results and lead to unreliable diagnostic information.
The FDA recall notice (Z-0403-2024) provides no specific guidance on recommended actions for users. Individuals or healthcare facilities with affected devices may wish to contact PATH or consult the FDA for further information regarding their specific units.
The recalled product
- Product
- AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
- Manufacturer
- PATH
- Hazard
- Affected units
- 23
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 04260223143298
- Serial Numbers: 260446-260468
Distribution
Part of a larger recall action
This product is one of 4 recalled by PATH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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