Young Dental Manufacturing I, LLC: Device Recall
Recall #Z-0008-2025 · 08/23/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0008-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Young Dental Manufacturing I, LLC
- Status
- Ongoing
- Date Initiated
- 08/23/2024
- Location
- Earth City, MO, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,391 units
Reason for Recall
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
Product Description
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Distribution Pattern
Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.
Other Recalls by Young Dental Manufacturing I, LLC
- Class II: Risk 05/13/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.