FDA Medical devices recall ·
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner recall
- Recall number
- Z-0008-2025
- Date
- (initiated August 23, 2024)
- Company / brand
- Young Dental Manufacturing I, LLC
13705 Shoreline Ct E, Earth City, MO, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,391 units
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Why was it recalled?
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089.
Distribution
Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.
States: Arizona Idaho Maryland Nevada New York Pennsylvania South Carolina Tennessee Texas Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0008-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.