FDAClass IIDecember 6, 2023

Audx PRO recall

AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP

Why was Audx PRO recalled?

Affected lots of product may experience technical distortions to a greater extent than expected.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 04260223143298; Serial Numbers: 260446-260468

Product
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
Recalling firm
PATH
Quantity
23 units
Distribution
US States: FL, MO, OH, WI
Recall date
December 6, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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