Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse recallZ-2143-2024 · Young Dental Manufacturing I, LLC · initiated May 13, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Young Dental Manufacturing I, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
FDA root cause category: Error in labeling
What the company is doing
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.
Recall details
- Recall number
- Z-2143-2024
- Status
- Open, Classified
- Initiated by the company
- May 13, 2024
- Posted by the FDA
- Jun 13, 2024
- Recalling firm
- Young Dental Manufacturing I, LLC
- Quantity
- 534 units
- Product code
- EJR
- Distribution
- US Nationwide distribution in the state of TN.
Product description
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Darby Dental Supply, LLC 9518637Darby Dental Supply, LLC · AGENT, POLISHING, ABRASIVE, ORAL CAVITY1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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