Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse

FDA Device Recall #Z-2143-2024 — Class II — May 13, 2024

Recall Summary

Recall Number Z-2143-2024
Classification Class II — Moderate risk
Date Initiated May 13, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Young Dental Manufacturing I, LLC
Location Earth City, MO
Product Type Devices
Quantity 534 units

Product Description

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

Distribution Pattern

US Nationwide distribution in the state of TN.

Lot / Code Information

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.

Other Recalls from Young Dental Manufacturing I, LLC

Recall # Classification Product Date
Z-0008-2025 Class II BIOTROL PURIT Clean-It General Purpose Ultrason... Aug 23, 2024
Z-0285-2024 Class II CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112.... Oct 6, 2023
Z-1697-2023 Class II BencoDental iris 5% NaF varnish, WHITE MINT ITE... May 23, 2023
Z-0725-2023 Class III Denticator PICK-A-DENT, periodontal aid - intra... Dec 5, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.