Inova Lasers Recalls Class IV New Era Medical Laser Devices
Inova Lasers LLC is recalling eight Class IV New Era medical laser devices because they failed to comply with Electronic Product Radiation Control regulations.
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, and the source text does not report any injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Inova Lasers LLC is recalling eight Class IV New Era medical laser devices. The recall was initiated because the firm failed to comply with applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.
The affected units were distributed nationwide in the United States. The source text does not specify the number of reported injuries or illnesses associated with this recall.
Consumers who possess these devices should contact Inova Lasers LLC for further instructions on how to proceed with the recall.
The recalled product
- Product
- Class IV New Era medical laser device
- Manufacturer
- Inova Lasers LLC
- Category
- Medical Device — Laser Device
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- New Era laser units
Distribution
Distributed nationwide across the United States.
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