FDA Medical Device Recalls (openFDA)
SANTA JOY ORNAMENT & GIFTWARE CO: 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.
- Recall number
- Z-1884-2018
- Recalling firm
- SANTA JOY ORNAMENT & GIFTWARE CO
- Product
- 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.
- Status
- Terminated
- Initiated
- 2017-11-21
- Posted
- not on file
- Terminated
- 2020-10-27
- Reason
- It was discovered that the product units it imported may, at peak levels, emit radiation that exceeds the federal standard for Class IIIa products.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 433,128
- Distribution
- USA (nationwide) distribution
- Lot, serial or model codes
- Model No: EZ-Illuminations Galaxy , EZ-Illuminations Northern Lights
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RDZ
- Firm FEI
- 3012680817
- Firm city
- Dongguan City
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28