Data Foundry

Medical device recalls 2025

Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton… — Class II medical device recall Z-1859-2025

Ongoing recall by Ultra Clean Systems, Inc., reported 2025-06-04, distributed nationwide. During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down

Recall numberZ-1859-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmUltra Clean Systems, Inc., Oldsmar, FL, United States
Recall initiated2025-03-31
Classified2025-05-28
Reported by FDA2025-06-04
DistributedNationwide (US)
Countries outside the USCA
Quantity96 systems
Reason classesspecification failure
UPC / GTIN / UDI-DI00816634020006, 00816634020013
Serial numbers1511-XL72-230-1, 1601-XL36-249-1, 1604-XL36-277-1, 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, 1808-XL36TR-596-1, 1809-XL72TR-611-1, 1810-XL36TR-618-1, 1905-XL36TR-707-1, 1907-XL36TR-721-1, 1910-XL72TR-788-1, 1911-XL36TR-800-1, 2001-XL36TR-834-1, 2002-XL72TR-844-1, 2004-XL36TR-859-1, 2004-XL36TR-873-1, 2004-XL72TR-878-1, 2004-XL72TR-879-1, 2005-XL72TR-881-1, 2006-XL72TR-890-1 and 71 more
Model numbers6003000804, 6003000805

Product

Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1859-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.