- Recalling firm
- Terex Utilities
- 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
- Affected products (lot / model / serial)
- Power Over Fiber Base Module Identification P/N 633232 P/N 622365 P/N 633383 P/N 633910 P/N 635731
- Units affected
- 101
- Distribution pattern
- U.S. Nationwide Distribution and International Distribution
- Firm location
- Watertown, SD, United States
- Recall type
- FDA Mandated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2745-2026
- Recall initiated
- May 11, 2026
- FDA classification date
- July 30, 2026
- FDA report date
- August 5, 2026
- FDA event ID
- 99382
- Last updated on HTM Vibe
- August 11, 2026