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Terex Utilities: Power Over Fiber Base Module

Medical DevicesSource: FDA (device) · Date: 2026-08-05

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Terex Utilities
Product
Power Over Fiber Base Module
Reason / hazard
Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for device. Improperly labeled - omitted labels required under 21 CFR 1040.10 / IEC 60825-1 via LN#56. Missing certification and proper manufacturer's ID label. Was not accompanied by compliant User Information. Formalized quality control procedures and record keeping of QC testing was not performed to IEC 60825-1 nor 21 CFR 1040.10 standards. Sales information did not convey required class designation and warning statement
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. Nationwide Distribution and International Distribution
Recall initiated
2026-05-11
Code info
Power Over Fiber Base Module Identification P/N 633232 P/N 622365 P/N 633383 P/N 633910 P/N 635731
Product quantity
101
Voluntary mandated
FDA Mandated
City
Watertown
State
SD
Country
United States
Event id
99382
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