Power Over Fiber Base Module recall (Terex Utilities)
Medical deviceClass IIOngoing
Summary: Terex Utilities is recalling Power Over Fiber Base Module. Reason: 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.
What is being recalled
Power Over Fiber Base Module
Why
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
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide Distribution and International Distribution
How to tell if yours is affected
Power Over Fiber Base Module Identification P/N 633232 P/N 622365 P/N 633383 P/N 633910 P/N 635731
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2745-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 11, 2026 |
| Reported | August 5, 2026 |
| Company | Terex Utilities |
| Company location | Watertown, SD, United States |
| Initiated by | FDA Mandated |
| Quantity | 101 |
More recalls from Terex Utilities · all medical device recalls · recalls from May 2026