Z-2745-2026 Class II Ongoing
FDA device recall Z-2745-2026 was initiated by Terex Utilities on May 11, 2026 and is designated Class II. 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. Improperl… The recall status is ongoing. Affected quantity: 101.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2026
- Initiation Date
- May 11, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 101
Product Description
Power Over Fiber Base Module
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 Pattern
U.S. Nationwide Distribution and International Distribution
Code Information
Power Over Fiber Base Module Identification P/N 633232 P/N 622365 P/N 633383 P/N 633910 P/N 635731