FDAClass IIAugust 10, 2022

CustMbite recall

CustMbite, Model Number CBT-SRS-UL

Why was CustMbite recalled?

The device was marketed and sold in the US without FDA clearance.

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: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222

Product
CustMbite, Model Number CBT-SRS-UL
Recalling firm
Dental Choice Holding Llc
Quantity
708
Distribution
US Nationwide distribution.
Recall date
August 10, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls