FDAClass IIDecember 6, 2023

Sentiero recall

SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098

Why was Sentiero 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: 04260223142437; Serial Numbers: 201015-201029

Product
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
Recalling firm
PATH
Quantity
15 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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