FDA Medical Device Recalls (openFDA)
Young Dental Manufacturing I, LLC: BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
- Recall number
- Z-0008-2025
- Recalling firm
- Young Dental Manufacturing I, LLC
- Product
- BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
- Status
- Open, Classified
- Initiated
- 2024-08-23
- Posted
- 2024-10-01
- Terminated
- not on file
- Reason
- The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
- 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
- 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.
- Lot, serial or model codes
- Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FLG
- Firm FEI
- 1941138
- Firm city
- Earth City
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28