Darby Prophylaxis Paste (Young Dental) – Mislabeling Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Brand
Young Dental Manufacturing I, LLC
Lot Codes / Batch Numbers
Unique Device Identifier (UDI)1: 00889813036273, Lot: 248607
Products Sold
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.
Young Dental Manufacturing I, LLC is recalling Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse due to Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026