Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.
FDA Recall Z-1884-2018 · Posted None
Recalling FirmSANTA JOY ORNAMENT & GIFTWARE CO
Recall StatusTerminated
Product CodeRDZ
Date Initiated2017-11-21
Date Terminated2020-10-27
Product Quantity433,128
Reason for Recall
It was discovered that the product units it imported may, at peak levels, emit radiation that exceeds the federal standard for Class IIIa products.
Firm Action
The Firm will bring the device into compliance by :
1. Santa Joy Ornament (SJO) will provide a full refund in exchange for the return of the models listed above. Returned products will be destroyed.
2. SJO has purchased optical measurement equipment and intends to measure the output of each laser product and ensure all laser products comply with applicable performance standards before shipment.
CDRH approves the CAP subject to the following conditions:
1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions, please call (410) 540-9840.
Root Cause
Nonconforming Material/Component
Distribution Pattern
USA (nationwide) distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.