| Date Initiated by Firm | May 11, 2026 |
| Date Posted | July 30, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2745-2026 |
| Recall Event ID |
99382 |
| Product Classification |
Fiber optic communication and data transfer - Product Code RFN
|
| Product | Power 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 Contact | Dan 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 |
| Action | A 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 Commerce | 101 |
| Distribution | U.S. Nationwide Distribution and International Distribution |
| Total Product Life Cycle | TPLC 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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