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FDA device recall Z-2675-2026 · posted 2026-07-21 · Open, Classified

Recall details

Recalling firm
Wilcox Industries Corp.
Reason for recall
Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be returned to implement this change.
Action taken
Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be returned to implement this change. Wilcox provided customers with contact information for our customer service as well to help facilitate returns and any questions. If this involved a medical device, has a Medical Device Report (MDR) been submitted to FDA?* Yes No N/A Unknown Other Important
Root cause
Radiation Control for Health and Safety Act
Status
Open, Classified
Product code
REU
Distribution
US Nationwide distribution in the state of NH.
Date initiated
2026-04-06
Date posted
2026-07-21
Location
Newington, NH

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