FDAClass IIJune 19, 2024

Darby Prophylaxis Paste with 1.23% Fluoride Ion recall

Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse

Why was Darby Prophylaxis Paste with 1.23% Fluoride Ion recalled?

Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032

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?

Unique Device Identifier (UDI)1: 00889813036273; Lot: 248607; Part number 040032 is the Young Dental part number. The Darby Dental Part Number (that is on the label) is 9518637.

Product
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Recalling firm
Young Dental Manufacturing I, LLC
Quantity
534 units
Distribution
US Nationwide distribution in the state of TN.
Recall date
June 19, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls