BIOTROL PURIT Cleaner (Young Dental) – Bacterial Contamination (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Brand
Young Dental Manufacturing I, LLC
Lot Codes / Batch Numbers
Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026, UDI-DI 00302730002089.
Products Sold
Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089.
Young Dental Manufacturing I, LLC is recalling BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes due to The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
Recommended Action
Per FDA guidance
The recalling firm issued letters on and dated 8/23/2024 via certified mail informing their direct consignees of the issue, potential health risks, and instructing their consignees to discard or return the affected product. An Acknowledgement and Receipt Form was enclosed to indicate the consignee has read and understands the recall instructions and asks if there have been any adverse events associated with the product. The response form instructs that if the consignee wishes to return the product, it should be sent to Young Dental Manufacturing for reimbursement. Follow-up letters were issued on and dated 9/11/2024 instructing the consignees to notify their downstream consignees to the user level. The letter also offers to notify the downstream consignees if their direct consignee requests it.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI
Page updated: Jan 10, 2026