Z-2745-2026Class II
Power Over Fiber Base Module
Terex Utilities / initiated 2026-05-11 / Open, Classified / root cause: labeling and UDI
Terex Utilities began a recall of Power Over Fiber Base Module on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-2745-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Terex Utilities
- Product
- Power Over Fiber Base Module
- Product code
- RFN Fiber Optic Communication And Data Transfer
- 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
- Root cause tag
- labeling and UDI
- FDA root cause
- 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: [email protected]
- Quantity in commerce
- 101
- Distribution
- U.S. Nationwide Distribution and International Distribution
- Product codes and lots
- Power Over Fiber Base Module Identification P/N 633232 P/N 622365 P/N 633383 P/N 633910 P/N 635731
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2745-2026 | Class II | Ongoing | FDA Mandated |
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