Data Foundry

Medical device recalls 2019

Lidar System for Erosion Flume Application Class 1 Laser Product… — Class II medical device recall Z-2100-2019

Ongoing recall by ASTRA, LLC, reported 2019-08-14, distributed nationwide. Failure to comply event due to incorrect labeling of a class 1 laser product.

Recall numberZ-2100-2019
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedFDA mandated
Recalling firmASTRA, LLC, Louisville, CO, United States
Recall initiated2019-04-25
Classified2019-08-07
Reported by FDA2019-08-14
DistributedNationwide (US)
Quantity1 product
Reason classeslabeling

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

Reason for recall

Failure to comply event due to incorrect labeling of a class 1 laser product.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2100-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.