FDA import alert
Import Alert 95-05
Detention Without Physical Examination of Electronic Products that Fail to Comply with Performance Standards or to Have Required Certification
101
Red-list entries
0
Green-list entries
6
Countries
2026-07-09
Last change seen
What being on this list means
Firms on an import alert's Red List are subject to Detention Without Physical Examination (DWPE): FDA can detain their shipments at the border automatically, without sampling or inspecting them. The burden shifts to the importer to prove — typically with private laboratory analysis, shipment by shipment — that the goods are not violative. Removal from the list requires evidence that the underlying problem is resolved, usually including a track record of consecutive clean shipments and a petition to FDA. How removal works →
A Green List on a countrywide alert works the other way: it names the firms FDA has excluded from detention because they demonstrated compliance.
Red-list entries by country
Firms on this red list
Showing 30 of 101 entries — search a specific firm on the free checker.
ACCTEK MACHINERY CO LTD
04/21/2025
China · Laser Cutter, Material Processing Laser Products; Laser Welder, Materials Processing Laser Products; Laser marker or engraver
ANHUI DONGHAI YUXIANG IMPORT & EXPORT CO.,LTD
01/09/2026
China · Laser Cutter, Material Processing Laser Products; Laser Welder, Materials Processing Laser Products; Print Industry Plate Maker, Material Processing Laser Products
BIG DIPPER LASER SCIENCE AND TEC
02/20/2024
China · General Purpose Laser Products, Non-Medical; Low-Power Laser Light Show Projector, Display Products; High-Power Laser Light Show Projector (Output>5mW)
BLUE SEA LIGHTING CO LIMITED
06/25/2025
China · Low-Power Laser Light Show Projector, Display Products; High-Power Laser Light Show Projector (Output>5mW); High-Power Laser Light Show, Display Products
Beijing Cosmelights Technology Co Ltd
12/10/2014
China · Powered laser surgical instruments; Light based over-the-counter hair removal; Powered light based non-laser surgical instrument
Beijing Laserworld Int'l Import & Export, Co., Ltd
10/04/2012
China · Laser Cutter, Material Processing Laser Products; Laser marker or engraver
Beijing Shizhengfang Science and Technology Dev. Co., LTD.
02/14/2013
China · Collimator, Dermatological, Therapeutic X-Ray; General Purpose Laser Products, Non-Medical; Laser therapy product
CHANGSHU WOJUN MACHINERY EQUIPME
12/27/2021
China · Laser marker or engraver
DONGGUAN MEIXINSI LIGHTING CO., LTD
02/23/2026
China · Low-Power Laser Light Show Projector, Display Products; High-Power Laser Light Show Projector (Output>5mW); High-Power Laser Light Show, Display Products
DONGGUAN ORTUR INTELLIGENT TECHNOLOGIES CO., LTD.
06/04/2025
China · General Purpose Laser Products, Non-Medical; Laser Cutter, Material Processing Laser Products; Laser marker or engraver
Dongguan Glorystar Laser Technolody Co., LTD
12/18/2024
China · Laser Cutter, Material Processing Laser Products; Laser Welder, Materials Processing Laser Products; Laser marker or engraver
Dongguan Yimei Sports Co., LTD
09/25/2024
China · Surveying Laser Product, Leveling, Alignment Laser Products; Alignment Laser Product, Surveying Leveling, Alignment Laser Products; Laser Pointer, Surveying, Leveling, Alignment Laser Products
E3 LASER SHENZHEN BEC LASER TECHCO LTD
07/19/2021
China · Laser marker or engraver
FOREST INDUSTRIAL HONG KONG LTD.
01/09/2026
China · Laser Illuminated Lighting Instrument
FORTUNE LASER TECHNOLOGY CO., LTD.
12/04/2025
China · Laser Cutter, Material Processing Laser Products; Print Industry Plate Maker, Material Processing Laser Products; Laser marker or engraver
GUANGDONG HONDU INTERNATIONAL SUPPLY CHAIN CO., LTD.
08/01/2025
China · General Purpose Laser Products, Non-Medical; Low-Power Laser Light Show Projector, Display Products; High-Power Laser Light Show, Display Products
GUANGZHOU FENGTAI IMPORT & EXPORT TRADING CO.,LTD
10/22/2024
China · High-Power Laser Light Show, Display Products; LED, General Purpose Illumination, General Optical Products, Non-Medical
GUANGZHOU SOL ELECTRONICS CO.
08/01/2025
China · General Purpose Laser Products, Non-Medical; Low-Power Laser Light Show Projector, Display Products; High-Power Laser Light Show, Display Products
GUANGZHOU XINYU STAGE LIGHTING INSTALLATION FACTORY
12/08/2025
China · Low-Power Laser Light Show Projector, Display Products; High-Power Laser Light Show Projector (Output>5mW); High-Power Laser Light Show, Display Products
Goldensign International Technology Co.Ltd
09/25/2019
China · Laser marker or engraver
GuangZhou Hua Yue Laser Co., Ltd.
08/11/2025
China · Laser Cutter, Material Processing Laser Products; Digital Display Monitor, General Optical Products, Non-Medical; Laser marker or engraver, tabletop, consumer
Guangzhou Han Ma Automation Control Equipment Co. Ltd.
08/20/2020
China · Portion of device code
Guangzhou Yue Xiu Enterprises Holdings Corp
09/16/2009
China · Microwave Oven, Consumer (Food Prep)
HEFEI COMMARKER TECHNOLOGY CO., LTD
12/23/2024
China · Laser Cutter, Material Processing Laser Products; Laser Welder, Materials Processing Laser Products; Laser marker or engraver
HK SISHUN TRADE CO., LTD
09/11/2020
China · Laser Cutter, Material Processing Laser Products; Portion of device code
HUIZHOU C-FLINK TECHNOLOGY CO., LTD.
07/30/2025
China · Fiber Optic Communication and Data Transfer, Laser; IR Free-Space Data Transmit/Control, Laser; Fiber optic instrument for testing optical fibers
HUIZHOU DAJIN TRADING CO.,LTD.
02/19/2026
China · Low-Power Laser Light Show Projector, Display Products; High-Power Laser Light Show Projector (Output>5mW); High-Power Laser Light Show, Display Products
JIANGSU BOFA ROBOT INTELLIGENT EQUIPMENT CO., LTD.
05/19/2026
China · Laser Cutter, Material Processing Laser Products; Laser Welder, Materials Processing Laser Products; Print Industry Plate Maker, Material Processing Laser Products
JILIN YONGLI LASER TECHNOLOGY COLTD
09/04/2025
China · Laser Cutter, Material Processing Laser Products; Laser Welder, Materials Processing Laser Products; Print Industry Plate Maker, Material Processing Laser Products
JINAN ACCTEK MACHI
04/21/2025
China · Laser Cutter, Material Processing Laser Products; Laser Welder, Materials Processing Laser Products; Laser marker or engraver
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