FDA import alert
Import Alert 80-06
Detention Without Physical Examination of Medical Devices with False or Misleading Labeling
27
Red-list entries
0
Green-list entries
11
Countries
2025-01-29
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.
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Red-list entries by country
Firms on this red list
Showing 27 of 27 entries — search a specific firm on the free checker.
- Q-Tech Laboratories
09/16/2009
Australia · Neurological
- Europe Cosmetiques
09/16/2009
Canada · Ear,Nose And Throat
Canada · Ear,Nose And Throat
- Nature Beaute Sante
09/16/2009
Canada · Ear,Nose And Throat
- Robert McFarland dba Radionics Institute
09/16/2009
Canada · General Hospital/Personal Use
- S A Wilson
09/16/2009
Canada · Kit, Enema, (For Cleaning Purpose)
Canada · Ear,Nose And Throat
Canada · Device, Biofeedback
China · Suture, Nonabsorbable, Synthetic, Polypropylene
China · Suture, Nonabsorbable, Synthetic, Polypropylene
- SHANGHAI SOTECH TECHNOLOGY CO
01/29/2025
China · Ophthalmic
- SHENZHEN RONG SHUO TECHNOLOGY
09/27/2024
China · Powered laser surgical instruments; LED, General Purpose Illumination, General Optical Products, Non-Medical
- Shanghai Electronics Componen
09/16/2009
China · General Hospital/Personal Use
China · Massager, Therapeutic, Electric
China · General Hospital/Personal Use
- Youda Electronics (Shenzhen) Co., Ltd.
01/29/2010
China · Powered laser surgical instruments; General Purpose Laser Products, Non-Medical
- Ace Integrated Solutions Ltd
01/29/2010
Hong Kong SAR · Powered laser surgical instruments; General Purpose Laser Products, Non-Medical
- MANDELAY KFT
09/16/2009
Hungary · Device, Biofeedback
- Globe Traders
09/16/2009
India · Mesh, Surgical, Polymeric
- Bridget Lifescience Co Ltd
11/22/2011
Korea (The Republic Of) · laser, dental, soft tissue
- M&H Co
11/22/2011
Korea (The Republic Of) · laser, dental, soft tissue
- Surgeon Surgical (Pvt) Ltd.
05/24/2011
Pakistan · Anesthesiology; Cardiovascular; Dental
- Alta Company
09/16/2009
Russia · Anesthesiology; Cardiovascular; Dental
Ukraine · Stimulator, Muscle, Powered
- Bruce Copen Laboratories
09/16/2009
United Kingdom · Anesthesiology; Cardiovascular; Dental
- Savec Health Systems
09/16/2009
United Kingdom · Generator, Oxygen, Portable
- Sussex College of Technology
09/16/2009
United Kingdom · Anesthesiology; Cardiovascular; Dental
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