Dental Ultrasonic Cleaner Recalled for Bacterial Contamination
Young Dental Manufacturing is recalling BIOTROL PURIT Clean-It Ultrasonic Cleaner (REF PC016) due to bacterial contamination in the bulk product used for repackaging. The recall affects 1,391 units distributed across 10 states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with confirmed bacterial contamination but no reported illnesses or injuries. Per the rubric, Class II recalls without hospitalization reports and with theoretical hazards score at 3 (High).
Plain-English summary
Young Dental Manufacturing I, LLC is recalling BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner (REF PC016, 16 fl oz) under FDA recall number Z-0008-2025. The product is a cleaning solution used in ultrasonic equipment in dental and medical settings.
The recall was initiated due to bacterial contamination detected in the bulk product used to manufacture the finished repackaged product. Approximately 1,391 units were affected and distributed to dental and medical facilities in Arizona, Idaho, Maryland, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas, and Wisconsin. The affected lot numbers are 247026, 255361, 234038, and 241667, all with an expiration date of June 13, 2026.
Customers who have purchased this product should stop using it immediately and contact Young Dental Manufacturing I, LLC to return or dispose of the product. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
- Manufacturer
- Young Dental Manufacturing I, LLC
- Hazard
- bacterial-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot numbers 247026
- 255361
- 234038
- and 241667
- exp. 6/13/2026
- UDI-DI 00302730002089.
Distribution
Distributed in 10 states:
- AZ
- ID
- MD
- NV
- NY
- PA
- SC
- TN
- TX
- WI
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