Z-0008-2025Class II

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

Name: Z-0008-2025 BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16...
Creator: Young Dental Manufacturing I, LLC
Published: 2024-08-23
License: https://open.fda.gov/license/

Young Dental Manufacturing Co 1, LLC. / initiated 2024-08-23 / Open, Classified / root cause: manufacturing process

FDA source

Young Dental Manufacturing I, LLC began a recall of BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution on 2024-08-23. FDA classified it as Class II and gives the reason as "The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0008-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-23
Posted: 2024-10-01
Recalling firm: Young Dental Manufacturing Co 1, LLC.
Product: BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Product code: FLG Cleaner, Ultrasonic, Medical Instrument
Reason for recall: The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: 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.
Quantity in commerce: 1,391 units
Distribution: Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.
Product codes and lots: Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0008-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0008-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-09	2024-10-01

Product code FLG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)