Class II

Medical Device Recall: BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

Young Dental Manufacturing I, LLC · August 23, 2024

Reason for Recall

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.

States Affected

AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI

Quantity Affected

1,391 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0008-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.