FDA Medical devices recall ·
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72… recall
- Recall number
- Z-1859-2025
- Date
- (initiated March 31, 2025)
- Company / brand
- Ultra Clean Systems, Inc.
110 Douglas Rd E, Oldsmar, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 96 systems
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
Why was it recalled?
During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Triton 36 Model Number 6003000804 UDI-DI code: 00816634020013 Serial Numbers: 1601-XL36-249-1 1604-XL36-277-1 1808-XL36TR-596-1 1810-XL36TR-618-1 1905-XL36TR-707-1 1907-XL36TR-721-1 1911-XL36TR-800-1 2001-XL36TR-834-1 2004-XL36TR-859-1 2004-XL36TR-873-1 2104-XL36TR-947-1 2201-XL36TR-001-1 2203-XL36TR-017-1 2306-XL36TR-050-1 2306-XL36TR-051-1 2307-XL36TR-053-1 2312-XL36TR-120-1 2401-XL36TR-001-1 2402-XL36TR-017-1 2402-XL36TR-018-1 2402-XL36TR-027-1 2402-XL36TR-028-1 2402-XL36TR-029-1 2402-XL36TR-030-1 2405-XL36TR-048-1 2405-XL36TR-049-1 2405-XL36TR-050-1 2405-XL36TR-051-1 2405-XL36TR-060-1 2405-XL36TR-061-1 2405-XL36TR-062-1 2405-XL36TR-063-1 2406-XL36TR-064-1 2406-XL36TR-065-1 2406-XL36TR-072-1 2406-XL36TR-074-1 2406-XL36TR-075-1 2407-XL36TR-079-1 2407-XL36TR-083-1 2409-XL36TR-101-1 2409-XL36TR-103-1 2409-XL36TR-105-1 2409-XL36TR-107-1 2409-XL36TR-109-1 2409-XL36TR-110-1 2410-XL36TR-111-1 2410-XL36TR-113-1 2410-XL36TR-114-1 2411-XL36TR-118-1 2411-XL36TR-122-1 2412-XL36TR-135-1 XL36TR4381 XL36TR4961 XL36TR5111 2307-XL36TR-055-1 Triton 72 Model Number 6003000805 UDI-DI code: 00816634020006 Serial Numbers: 1511-XL72-230-1 1606-XL72-291-1 1706-XL72TR-401-1 1805-XL72TR-544-1 1805-XL72TR-546-1 1806-XL72TR-564-1 1806-XL72TR-565-1 1807-XL72TR-568-1 1809-XL72TR-611-1 1910-XL72TR-788-1 2002-XL72TR-844-1 2004-XL72TR-878-1 2004-XL72TR-879-1 2005-XL72TR-881-1 2006-XL72TR-890-1 2103-XL72TR-929-1 2103-XL72TR-930-1 2104-XL72TR-946-1 2112-XL72TR-1022-1 2202-XL72TR-013-1 2202-XL72TR-014-1 2202
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.
States: Arizona California Colorado Florida Idaho Illinois Indiana Kansas Massachusetts Maryland Michigan Minnesota Missouri North Carolina New Hampshire New Jersey Nevada New York Ohio Oregon Pennsylvania South Dakota Texas Virginia Washington Wisconsin Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1859-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.