FirstAlerts

FDA Enforcement Report Details Class II Recall of Terex Utilities Power Over Fiber Modules

Official FDA records classify a nationwide and international recall of 101 Power Over Fiber Base Modules due to certification and labeling issues.

4 reports on this incident · first at Aug 20, 2026, 8:14 a.m. ET

By AI ReporterWritten Aug 20, 2026, 8:52 a.m. ET
On August 5, 2026, the U.S. Food and Drug Administration issued an enforcement report regarding an recall of 101 Power Over Fiber Base Modules distributed by , based in . The recall was initiated on May 11, 2026, under recall number , covering products sent through U.S. nationwide and international distribution. According to FDA records, the recall covers part numbers P/N 633232, P/N 622365, P/N 633383, P/N 633910, and P/N 635731. The agency recorded that the device was not certified because no laser product report was filed with the Center for Devices and Radiological Health (CDRH) prior to distribution. The product label incorrectly states the device is "Class IV", although Class 1 is appropriate for the device. The FDA report noted that the modules omitted required labels under 21 CFR 1040.10 / IEC 60825-1 via LN#56, lacked certification and proper manufacturer's ID labels, were not accompanied by compliant User Information, and omitted required class designation and warning statements from sales information. Additionally, formalized quality control procedures and record keeping of QC testing were not performed to IEC 60825-1 nor 21 CFR 1040.10 standards. is defined by the FDA as a category used where exposure to a product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. FDA database records list no other enforcement actions for . The notice specifies no remedy instructions for the units.

Earlier reports

  1. Aug 20, 2026, 8:23 a.m. ET

    FDA Designates Class II Hazard Classification for Terex Utilities Recall

    On August 5, 2026, the FDA designated the ongoing recall of Power Over Fiber Base Modules from Terex Utilities as a Class II action under recall number Z-2745-2026. The FDA defines Class II as a classification used where exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

    The recall covers 101 Power Over Fiber Base Modules distributed nationwide in the U.S. and internationally by Watertown-based Terex Utilities. The action applies to modules carrying identification part numbers P/N 633232, P/N 622365, P/N 633383, P/N 633910, and P/N 635731, following an initial recall date of May 11, 2026.

    According to the FDA enforcement report, the device was not certified and no laser product report was filed with CDRH prior to distribution. The FDA noted that the product label incorrectly states the device is "Class IV", although Class 1 is appropriate for the device. Additionally, the units omitted labels required under 21 CFR 1040.10 / IEC 60825-1 via LN#56, lacked certification and proper manufacturer ID labels, were not accompanied by compliant User Information, lacked formalized quality control procedures and record keeping under IEC 60825-1 or 21 CFR 1040.10 standards, and sales information did not convey required class designation and warning statements. FDA enforcement databases list no other actions for Terex Utilities.

  2. Aug 20, 2026, 8:20 a.m. ET

    FDA Enforcement Action Closed for Terex Utilities Power Over Fiber Base Modules

    The FDA has closed its recall action for 101 Power Over Fiber Base Modules manufactured by Watertown-based Terex Utilities, indicating the agency considers the recall carried out. According to an FDA enforcement report dated August 5, 2026, the voluntary recall was originally initiated on May 11, 2026. The action applies to devices with the identifying codes Power Over Fiber Base Module Identification P/N 633232 P/N 622365 P/N 633383 P/N 633910 P/N 635731.

    FDA enforcement records state that the device had U.S. nationwide and international distribution. The recall, registered under recall number Z-2745-2026, was initiated because the device was not certified and no laser product report was filed with the CDRH prior to distribution. Official records also note that the product label incorrectly listed the device as "Class IV" when Class 1 is appropriate, omitted required labels under 21 CFR 1040.10 / IEC 60825-1 via LN#56, lacked certification and a proper manufacturer's ID label, was not accompanied by compliant user information, lacked formalized quality control procedures and record keeping to IEC 60825-1 or 21 CFR 1040.10 standards, and omitted required class designations and warning statements in sales information.

    The agency categorized the recall as Class II. According to official FDA definitions, Class II designates a situation where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA database records document no other enforcement actions for Terex Utilities.

  3. Aug 20, 2026, 8:14 a.m. ETFirst report

    Terex Utilities Recalls Power Over Fiber Base Modules Over Certification and Labeling Issues

    On August 5, 2026, an official FDA enforcement report published details on an ongoing product recall initiated on May 11, 2026, by Terex Utilities of Watertown. The recall applies to 101 units of the Power Over Fiber Base Module, under part numbers P/N 633232, P/N 622365, P/N 633383, P/N 633910, and P/N 635731. Distribution was listed as U.S. Nationwide Distribution and International Distribution.

    According to official FDA enforcement records for recall number Z-2745-2026, the device was not certified and no laser product report was filed with CDRH prior to distribution. The product label incorrectly states the device is "Class IV", although Class 1 is appropriate. Official records also note that labels required under 21 CFR 1040.10 / IEC 60825-1 via LN#56 were omitted, certification and proper manufacturer's ID labels were missing, compliant User Information was not provided, formalized quality control procedures and QC testing record keeping were not performed to IEC 60825-1 nor 21 CFR 1040.10 standards, and sales information failed to convey the required class designation and warning statement.

    The agency classified the action as a Class II recall. Class II is the FDA's middle category, used where a product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. FDA database records list no other enforcement actions for Terex Utilities. The status of the recall remains ongoing.

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Revision history

  1. Version 120 Aug 2026, 12:52current

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  2. Version 120 Aug 2026, 12:14current

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  3. Version 120 Aug 2026, 12:23current

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  4. Version 120 Aug 2026, 12:20current

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