Ultrasonic Cleaning Systems recallZ-1859-2025 · Ultra Clean Systems, Inc. · initiated Mar 31, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ultra Clean Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.
FDA root cause category: Under Investigation by firm
What the company is doing
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 your unit has been impacted by this issue. -Complete and sign the attached response form to acknowledge that they have received the notification. Return the completed form to Getinge by emailing a scanned copy to [email protected] Public contact for questions/assistance - [email protected]
Recall details
- Recall number
- Z-1859-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 31, 2025
- Posted by the FDA
- May 28, 2025
- Recalling firm
- Ultra Clean Systems, Inc.
- Quantity
- 96 systems
- Product code
- FLG
- 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.
Product description
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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-XL72TR-015-1 2203-XL72TR-016-1 2207-XL72TR-045-1 2211-XL72TR-088-1 2304-XL72TR-028-1 2305-XL72TR-030-1 2305-XL72TR-034-1 2309-XL72TR-073-1 2310-XL72TR-099-1 2402-XL72TR-023-1 2402-XL72TR-024-1 2404-XL72TR-047-1 2405-XL72TR-052-1 2405-XL72TR-053-1 2406-XL72TR-073-1 2407-XL72TR-080-1 2407-XL72TR-084-1 2409-XL72TR-104-1 2411-XL72TR-120-1 XL72TR4401
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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