United Nuclear Scientific High Power Handheld Lasers. Laser products
FDA Recall Z-0051-2018 · Posted None
Recalling FirmUnited Nuclear Scientific Supplies, LLC
Recall StatusTerminated
Product CodeREA
Date Initiated2016-08-25
Date Terminated2020-10-27
Product Quantity3
Reason for Recall
Failure to comply with the laser class limitation listed in the performance standard for Specific Use Laser products.
Firm Action
United Nuclear will bring defect into compliance by :
The Center for Devices and Radiological Health (CDRH) understands that the CAP involving three units will consist of the following:
1. Notification will be given to purchasers per 21 CFR 1003.21.
2 .A full refund will be offered to all purchasers upon return of their laser pointers.
3. Postage paid shipping containers will be provided to all purchasers for the return of the laser pointers.
Please note that United Nuclear Scientific Supplies, LLC is responsible for the correction of all noncompliant products
If you have any questions, please call (517) 339-3587, or email : [email protected]
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
US Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.