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RecallWatchMedical Device Safety
Class IIOngoingZ-1859-2025

Ultra Clean Systems, Inc. recalls Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number…

Ultra Clean Systems, Inc.Oldsmar, FL, United StatesReported Jun 4, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
    UDI-DI codeModel Number
    98 affected lots
    1601-XL36-249-11604-XL36-277-11808-XL36TR-596-11810-XL36TR-618-11905-XL36TR-707-11907-XL36TR-721-11911-XL36TR-800-12001-XL36TR-834-1
    +90 more2004-XL36TR-859-12004-XL36TR-873-12104-XL36TR-947-12201-XL36TR-001-12203-XL36TR-017-12306-XL36TR-050-12306-XL36TR-051-12307-XL36TR-053-12312-XL36TR-120-12401-XL36TR-001-12402-XL36TR-017-12402-XL36TR-018-12402-XL36TR-027-12402-XL36TR-028-12402-XL36TR-029-12402-XL36TR-030-12405-XL36TR-048-12405-XL36TR-049-12405-XL36TR-050-12405-XL36TR-051-12405-XL36TR-060-12405-XL36TR-061-12405-XL36TR-062-12405-XL36TR-063-12406-XL36TR-064-12406-XL36TR-065-12406-XL36TR-072-12406-XL36TR-074-12406-XL36TR-075-12407-XL36TR-079-12407-XL36TR-083-12409-XL36TR-101-12409-XL36TR-103-12409-XL36TR-105-12409-XL36TR-107-12409-XL36TR-109-12409-XL36TR-110-12410-XL36TR-111-12410-XL36TR-113-12410-XL36TR-114-12411-XL36TR-118-12411-XL36TR-122-12412-XL36TR-135-1XL36TR4381XL36TR4961XL36TR51112307-XL36TR-055-16003000805008166340200061511-XL72-230-11606-XL72-291-11706-XL72TR-401-11805-XL72TR-544-11805-XL72TR-546-11806-XL72TR-564-11806-XL72TR-565-11807-XL72TR-568-11809-XL72TR-611-11910-XL72TR-788-12002-XL72TR-844-12004-XL72TR-878-12004-XL72TR-879-12005-XL72TR-881-12006-XL72TR-890-12103-XL72TR-929-12103-XL72TR-930-12104-XL72TR-946-12112-XL72TR-1022-12202-XL72TR-013-12202-XL72TR-014-12202-XL72TR-015-12203-XL72TR-016-12207-XL72TR-045-12211-XL72TR-088-12304-XL72TR-028-12305-XL72TR-030-12305-XL72TR-034-12309-XL72TR-073-12310-XL72TR-099-12402-XL72TR-023-12402-XL72TR-024-12404-XL72TR-047-12405-XL72TR-052-12405-XL72TR-053-12406-XL72TR-073-12407-XL72TR-080-12407-XL72TR-084-12409-XL72TR-104-12411-XL72TR-120-1XL72TR4401

What the firm 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 recallresponses.qrc@getinge.com Public contact for questions/assistance - recalls.qrc@getinge.com

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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