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Recall Observatory FDA recall evidence

Device product

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

Z-0008-2025

August 23, 2024

Class II

Product summary

Firm
Young Dental Manufacturing I, LLC
Event
Event 95302
Status
Ongoing
Classification
Class II
Quantity
1,391 units
Official record key
device-enforcement:Z-0008-2025

Official wording

Reason: The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.

Code information: Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089.

Distribution pattern: Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    bacterial contamination