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FDA · Medical device recall

Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic…

Recall started · FDA enforcement report June 4, 2025 Class II

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

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Enforcement report date
June 4, 2025
Risk class
Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status
Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
Filed by
Ultra Clean Systems, Inc.
Product
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
Reason
During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.
Distribution pattern
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.
Quantity
96 systems
Codes and lots
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
Recall started
March 31, 2025
Voluntary or mandated
Voluntary: Firm initiated
Device type
Cleaner, Ultrasonic, Medical Instrument
Root cause (FDA)
Under Investigation by firm
What the company told customers
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
Recall number
Z-1859-2025

What this record is about

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A generic icon of the kind of thing the record is aboutA simplified icon of the kind of thing the record is about and the phrases of the record's own text beside it.1 The record: Ultrasonic Cleaning Systems Triton 36 Model…2 In the record's words:3 Only the kind of thing is drawn4 The record's own words are below“During routine preventative maintenance checks, it was revealed thatcarbon filter sensors were breaking down due to electrochemical…”ULTRASONIC CLEANING…

“During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.”Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system, FDA enforcement report, 2025-06-04. The caption is the record's own words.

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FDA device name: Cleaner, Ultrasonic, Medical Instrument

Distributed in (FDA's record): Arizona California Colorado Florida Idaho Illinois Indiana Kansas Maryland Massachusetts Michigan Minnesota Missouri Nevada New Hampshire New Jersey New York North Carolina Ohio Oregon Pennsylvania South Dakota Texas Virginia Washington Wisconsin Wyoming and nationwide

This recall among the others

  • FDA's enforcement report came 65 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).

Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement report, recall number Z-1859-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

Cite this record
FDA recall record Z-1859-2025, June 4, 2025. "Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic." PlainRecords, https://plainrecords.com/recall/device/z-1859-2025/ (as of the day it was built).

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