BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner… recallZ-0008-2025 · Young Dental Manufacturing I, LLC · initiated Aug 23, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Young Dental Manufacturing I, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
FDA root cause category: Material/Component Contamination
What the company is doing
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.
Recall details
- Recall number
- Z-0008-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 23, 2024
- Posted by the FDA
- Oct 1, 2024
- Recalling firm
- Young Dental Manufacturing I, LLC
- Quantity
- 1,391 units
- Product code
- FLG
- Distribution
- Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.
Product description
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Code information (models, lots, serial numbers)
Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Biotrol PC016Young Dental Manufacturing I, LLC · Cleaner, Ultrasonic, Medical Instrument1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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