Recall Z-1859-2025 ยท FLG Cleaner, Ultrasonic, Medical Instrument
Ultra Clean Systems, Inc.
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
| Date | May 28, 2025 (initiated Mar 31, 2025) |
| Status | Open, Classified |
| Reason | During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation. |
| Root cause | Under Investigation by firm |
| Action | On 03/31/2025, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter via FedEx to customers informing them that as a result of an investigation, it has been revealed that a combination of chemical and electrical interactions that result in electrochemical degradation, compromising the structural integrity of the sensor over time. This degradation could potentially lead to water leakage into the machine. On 04/25/2025, the firm sent via FedEx and updated letter. Customers are notified and/or instructed that/to: -A field technicians will be contacting you to arrange for replacement if you |
| Quantity | 96 systems |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AZ, CA, CO, FL, ID, IL, IN, KS, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SD, TX, VA, WA, WI, and WY. The country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.