Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2675-2026Class II

The intended use is to be paired with a weapon for aiming purposes

Wilcox Industries Corp. / initiated 2026-04-06 / Open, Classified / root cause: software

Wilcox Industries Corp. began a recall of The intended use is to be paired with a weapon for aiming purposes on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number
Z-2675-2026
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Wilcox Industries Corp.
Product
The intended use is to be paired with a weapon for aiming purposes.
Product code
REU Laser Aiming Product, Visible
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.
Root cause tag
software
FDA root cause
Radiation Control for Health and Safety Act
Action
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
Distribution
US Nationwide distribution in the state of NH.
Product codes and lots
None provided.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2675-2026
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2675-2026Class IIOngoingFDA Mandated