Power Over Fiber Base Modules Recalled Due to Incorrect Laser Classification and Labeling
Terex Utilities is recalling Power Over Fiber Base Modules because the devices lack proper laser certification and contain incorrect safety labeling regarding their laser class.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, involving labeling errors and missing required documentation/certifications, which falls under the rubric for moderate severity.
Plain-English summary
Terex Utilities is recalling Power Over Fiber Base Modules (P/N 633232, 622365, 633383, 633910, and 635731). The recall was initiated because the devices were distributed without a required laser product report being filed with the CDRH. Additionally, the product labels incorrectly state the device is "Class IV" when "Class 1" is the appropriate designation.
The devices lack required labels under 21 CFR 1040.10 / IEC 60825-1, are missing a manufacturer's ID label, and were not accompanied by compliant User Information. Furthermore, quality control procedures and record keeping for testing were not performed according to IEC 60825-1 or 21 CFR 1040.10 standards.
This recall affects products distributed nationwide in the U.S. and internationally.
The recalled product
- Product
- Power Over Fiber Base Module
- Manufacturer
- Terex Utilities
- Category
- Medical Device — Laser Equipment
- Affected units
- 101
Distribution
Distributed nationwide across the United States.
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