BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner — Class II medical device recall Z-0008-2025
Ongoing recall by Young Dental Manufacturing I, LLC, reported 2024-10-09, distributed in AZ, ID, MD, NV, NY, PA, SC, TN…. The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contam
| Recall number | Z-0008-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Young Dental Manufacturing I, LLC, Earth City, MO, United States |
| Recall initiated | 2024-08-23 |
| Classified | 2024-10-01 |
| Reported by FDA | 2024-10-09 |
| Distributed | AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI |
| Quantity | 1,391 units |
| Reason classes | microbial contamination |
| UPC / GTIN / UDI-DI | 00302730002089 |
| Lot numbers | 234038, 241667, 247026, 255361 |
| Model numbers | PC016 |
| Expiration dates | 2026-06-13 |
Product
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Reason for recall
The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0008-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.