ASTRA Lidar System Recalled for Incorrect Class 1 Laser Labeling
ASTRA, LLC is recalling one Lidar System for Erosion Flume Application due to incorrect labeling of a Class 1 laser product.
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 involves a labeling error without reported injuries, fitting the criteria for moderate severity.
Plain-English summary
ASTRA, LLC is recalling one Lidar System for Erosion Flume Application, Model L1, identified by Accession No. RH19A0069. The product is a Class 1 laser system installed and fixed above a dynamic indoor flume designed for modeling water erosion in an indoor research environment with limited human access.
The recall was initiated due to a failure to comply event involving the incorrect labeling of the Class 1 laser product. The source text does not specify the nature of the labeling error or any reported injuries or illnesses.
The product was distributed nationwide in the United States. Users of the affected Lidar System should contact the recalling firm for further instructions regarding the recall.
The recalled product
- Product
- Lidar System for Erosion Flume Application Class 1 Laser Product Product Usage: Product is installed and fixed above a dynamic indoor flume designed for modeling water erosion in an indoor research environment with limited human access
- Manufacturer
- ASTRA, LLC
- Category
- Medical Device — Laser Product
- Hazard
- Affected units
- 1
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 (2)
- Model: L1
- identified by Accession No. RH19A0069
Distribution
Distributed nationwide across the United States.
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