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U.S. Department of Health and Human Services

Class 2 Device Recall Power Over Fiber Base Module

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 Class 2 Device Recall Power Over Fiber Base Modulesee related information
Date Initiated by FirmMay 11, 2026
Date PostedJuly 30, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2745-2026
Recall Event ID 99382
Product Classification Fiber optic communication and data transfer - Product Code RFN
ProductPower Over Fiber Base Module
Code Information Power Over Fiber Base Module Identification P/N 633232 P/N 622365 P/N 633383 P/N 633910 P/N 635731
FEI Number 3005768141
Recalling Firm/
Manufacturer
Terex Utilities
600 Oakwood Rd
Watertown SD 57201-4140
For Additional Information ContactDan Brenden
605-882-4000
Manufacturer 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
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
ActionA 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: dan.brenden@terex.com
Quantity in Commerce101
DistributionU.S. Nationwide Distribution and International Distribution
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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