FDA Medical Device Recalls (openFDA)
Young Dental Manufacturing I, LLC: Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
- Recall number
- Z-2143-2024
- Recalling firm
- Young Dental Manufacturing I, LLC
- Product
- Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
- Status
- Open, Classified
- Initiated
- 2024-05-13
- Posted
- 2024-06-13
- Terminated
- not on file
- Reason
- Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
- 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
- 534 units
- Distribution
- US Nationwide distribution in the state of TN.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EJR
- Firm FEI
- 1941138
- Firm city
- Earth City
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28