Earth City, MO, United States
Young Dental Manufacturing I, LLC recalls
5 recalls recorded since 2018, most recently on 23 August 2024. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)5
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 August 2024
- Reason
- The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
- Distribution
- Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0008-2025
- BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Ongoing Class II Medical devices
- Recall started
- 13 May 2024
- Reason
- Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032
- Distribution
- US Nationwide distribution in the state of TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2143-2024
- Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Ongoing Class II Medical devices
- Recall started
- 6 October 2023
- Reason
- one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.
- Distribution
- US: IN, TN, MO
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0285-2024
- CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
Ongoing Class II Medical devices
- Recall started
- 23 May 2023
- Reason
- The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.
- Distribution
- US distribution to Florida, Nevada, and Pennsylvania.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1697-2023
- BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
Ongoing Class III Medical devices
- Recall started
- 5 December 2022
- Reason
- mislabeled product
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of IA, NY, PA, TN, TX, and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0725-2023
- Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.