Darby Prophylaxis Paste with 1 — Class II medical device recall Z-2143-2024
Ongoing recall by Young Dental Manufacturing I, LLC, reported 2024-06-19, distributed nationwide. Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
| Recall number | Z-2143-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Young Dental Manufacturing I, LLC, Earth City, MO, United States |
| Recall initiated | 2024-05-13 |
| Classified | 2024-06-13 |
| Reported by FDA | 2024-06-19 |
| Distributed | Nationwide (US) |
| Quantity | 534 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00889813036273 |
| Lot numbers | 248607 |
| Model numbers | 040032, 9518637 |
Product
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Reason for recall
Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2143-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.