FDA Device recall Z-0008-2025
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution
- FDA Device
- Class II
- ongoing
- Published 2024-10-09
On 2024-10-09 the FDA classified a Class II recall of BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution by Young Dental Manufacturing I, citing the bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0008-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-23 |
| Published | 2024-10-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Young Dental Manufacturing I |
| Distribution | AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI |
Product
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Reason
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
Identifiers
| code_info | Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0008-2025%22
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