Medical Device Recall: Power Over Fiber Base Module
Terex Utilities · May 11, 2026
Reason for Recall
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
Distribution
U.S. Nationwide Distribution and International Distribution
States Affected
NATIONWIDE
Quantity Affected
101
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2745-2026
Status: ongoing
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