Z-2143-2024Class II

Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse

Name: Z-2143-2024 Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Creator: Young Dental Manufacturing I, LLC
Published: 2024-05-13
License: https://open.fda.gov/license/

Young Dental Manufacturing Co 1, LLC. / initiated 2024-05-13 / Open, Classified / root cause: labeling and UDI

FDA source

Young Dental Manufacturing I, LLC began a recall of Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse on 2024-05-13. FDA classified it as Class II and gives the reason as "Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2143-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-13
Posted: 2024-06-13
Recalling firm: Young Dental Manufacturing Co 1, LLC.
Product: Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Product code: EJR Agent, Polishing, Abrasive, Oral Cavity
Reason for recall: Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The FSN was sent to the consignee on ___ via certified mail. The consignee was asked to: 1. Please forward this notification to any customers who purchased the affected devices from you; 2. Reformat this notification to a header indicating the company's and part number; 3. If the customer wishes to receive a replacement or refund as reimbursement they should contact the distributor directly. Young Dental will then credit or replace the item; 4. If the customer wants the firm to contact their customers directly, please send us a list of the customers and their contact details. The firm will send this letter to them.
Quantity in commerce: 534 units
Distribution: US Nationwide distribution in the state of TN.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2143-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2143-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-13

Product code EJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)