FDA import alert
Import Alert 89-08
Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)
1,059
Red-list entries
0
Green-list entries
53
Countries
2026-05-19
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
| Country | Entries |
|---|---|
| China | 409 |
| Korea (The Republic Of) | 107 |
| Canada | 75 |
| United Kingdom | 75 |
| Germany | 50 |
| Hong Kong SAR | 41 |
| Taiwan | 34 |
| Italy | 27 |
| Switzerland | 25 |
| France | 21 |
| India | 21 |
| South Africa | 15 |
| Japan | 14 |
| Singapore | 13 |
| Malaysia | 9 |
| Turkey | 9 |
| United States | 9 |
| Australia | 8 |
| Israel | 7 |
| Netherlands | 7 |
| Sweden | 7 |
| Czech Republic | 6 |
| Denmark | 5 |
| Mexico | 5 |
| Belgium | 4 |
+ 28 more countries
Firms on this red list
Showing 30 of 1,059 entries — search a specific firm on the free checker.
Lebian International S R L
05/16/2014
Argentina · Portion of device code
Dr Ashely Minas
06/24/2015
Armenia · Implant, Dermal, Collagen for Aesthetic Use
Dr. Ashley Minas
06/24/2015
Armenia · Implant, Dermal, Collagen for Aesthetic Use
Australian Light Therapy
09/16/2009
Australia · Anesthesiology; Cardiovascular; Dental
Better Breathing Devices Pty Ltd
10/16/2023
Australia · Spirometer, Therapeutic (Incentive); Percussor, Powered-Electric
Bionic Products Pty., Ltd.
12/20/2018
Australia · Anesthesiology; Cardiovascular; Dental
Genetic Signatures Limited
01/21/2022
Australia · Reagents, 2019-novel coronavirus nucleic acid
MELBOURNE BIOTECH
10/20/2020
Australia · Reagents, 2019-novel coronavirus nucleic acid; Reagent, coronavirus serological; Coronavirus antigen detection test system.
Medec Pty Ltd
09/16/2009
Australia · Massager, Therapeutic, Electric
PROMEDICAL EQUIPMENT PTY LTD
06/22/2020
Australia · Reagents, 2019-novel coronavirus nucleic acid; Reagent, coronavirus serological; Coronavirus antigen detection test system.
Planet Innovation Pty Ltd
08/31/2021
Australia · Colorimeter, Photometer, Spectrophotometer For Clinical Use
IHT Ltd
09/16/2009
Bahamas · Immunology
Newco Associates Limited
09/16/2009
Bahamas · Immunology
Biocartis Nv
12/07/2021
Belgium · Reagents, 2019-novel coronavirus nucleic acid
Coris Bioconcept
07/27/2021
Belgium · Coronavirus antigen detection test system.
MULTI-G BVBA
01/26/2021
Belgium · Reagent, coronavirus serological
ZenTech SA
03/02/2021
Belgium · Reagent, coronavirus serological
Dynamax
06/20/2019
British Virgin Islands · Dental; Ear,Nose And Throat; Orthopedic
Hadaco Ltd
06/20/2019
British Virgin Islands · Dental; Ear,Nose And Throat; Orthopedic
Tranquil Prospects
06/20/2019
British Virgin Islands · Dental; Ear,Nose And Throat; Orthopedic
World Health Diagnostics, Inc.
09/16/2009
British Virgin Islands · Biological In-Vivo and In-Vitro Diagnostics, N.E.C.; Immunology
TAMPON INNOVATIONS LTD.
07/17/2025
Bulgaria · Tampon, Menstrual, Unscented
A & T Company
09/16/2009
Canada · Biological In-Vivo and In-Vitro Diagnostics, N.E.C.; Immunology
Active Chi Enterprises Corp
07/21/2017
Canada · Apparatus, traction, non-powered
Acumed Medical Supplies Ltd
03/08/2011
Canada · Stimulator, Electro-Acupuncture
Angel & Company
09/16/2009
Canada · Monitor, Breathing Frequency
Anogen Division of Yes Biotech Lab
09/16/2009
Canada · Biological In-Vivo and In-Vitro Diagnostics, N.E.C.; Immunology
Anti Aging Solutions Inc.
09/16/2009
Canada · Anesthesiology; Cardiovascular; Dental
Applied Biological Materials Inc
01/06/2022
Canada · Reagents, 2019-novel coronavirus nucleic acid
Aqua Sole Company Ltd
09/16/2009
Canada · Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear)
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