Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2745-2026Class II

Power Over Fiber Base Module

Terex Utilities / initiated 2026-05-11 / Open, Classified / root cause: labeling and UDI

Terex Utilities began a recall of Power Over Fiber Base Module on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-2745-2026
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Terex Utilities
Product
Power Over Fiber Base Module
Product code
RFN Fiber Optic Communication And Data Transfer
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
Root cause tag
labeling and UDI
FDA root cause
Radiation Control for Health and Safety Act
Action
A letter was received stating the product, problem and actions to be taken. The following actions being taken include: A. Develop and carry out a process to remove incorrect labeling and install all labels required under IEC 60825-1 2014. B. Generate, detail & submit full CAP (Corrective Action Plan) for FDA approval C. Generate initial laser product report or supplemental as appropriate. D. Equipment update to be performed by Terex personnel at customer location E. Procedures: * Fully certify device as Class 1 under the guidelines of FDA Laser Notice #56 by applying the IEC 60825-1 2014 laser certification standard * Update and distribute compliant UI (User Information) * Update Sales information as appropriate * Generate and apply administrative and safety labeling * Formalized quality control procedures and record keeping. If you have any questions, contact Director of Engineering at +16058824000 or email: [email protected]
Quantity in commerce
101
Distribution
U.S. Nationwide Distribution and International Distribution
Product codes and lots
Power Over Fiber Base Module Identification P/N 633232 P/N 622365 P/N 633383 P/N 633910 P/N 635731

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2745-2026
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2745-2026Class IIOngoingFDA Mandated