Power Over Fiber Base Module

Summary

The FDA issued a Class II for Power Over Fiber Base Module by Terex Utilities. Reason: Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", alth.

Details

Product Description

Power Over Fiber Base Module

Lot/Code Info: Power Over Fiber Base Module Identification P/N 633232 P/N 622365 P/N 633383 P/N 633910 P/N 635731

Quantity Affected: 101

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

Type: FDA Mandated

Recall Initiated: 2026-05-11

Company