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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmApril 06, 2026
Date PostedJuly 21, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2675-2026
Recall Event ID 99059
Product Classification Laser aiming product, visible - Product Code REU
ProductThe intended use is to be paired with a weapon for aiming purposes.
Code Information None provided.
FEI Number 3007858386
Recalling Firm/
Manufacturer
Wilcox Industries Corp.
25 Piscataqua Dr
Newington NH 03801-7816
Manufacturer 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.
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
ActionWilcox 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
DistributionUS Nationwide distribution in the state of NH.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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