FDA Device recall Z-2143-2024
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
- FDA Device
- Class II
- ongoing
- Published 2024-06-19
On 2024-06-19 the FDA classified a Class II recall of Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse by Young Dental Manufacturing I, citing part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2143-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-13 |
| Published | 2024-06-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Young Dental Manufacturing I |
| Distribution | US |
Product
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Reason
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
Identifiers
| code_info | Unique Device Identifier (UDI)1: 00889813036273; Lot: 248607; Part number 040032 is the Young Dental part number. The D…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2143-2024%22
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