FDA import alert
Import Alert 89-04
Detention Without Physical Examination of Devices from Firms that Have not met Device Quality System Requirements
177
Red-list entries
0
Green-list entries
30
Countries
2026-07-02
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
+ 5 more countries
Firms on this red list
Showing 30 of 177 entries — search a specific firm on the free checker.
Cidal Sa
09/16/2009
Argentina · Condom
F.P. Rubinstein Y Cia SRL
04/20/2016
Argentina · Anesthesiology; Cardiovascular; Dental
Unimed
09/16/2009
Argentina · Catheter, Embolectomy; Stents, drains and dilators for the biliary ducts; Catheter, Continuous Irrigation
Advanced Surgical Design & Manufacture, Ltd.
12/06/2010
Australia · Tray, Surgical; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Screw, Fixation, Bone
CIGWELD
09/16/2009
Australia · Ventilator, Emergency, Manual (Resuscitator)
TFS MANUFACTURING PTY LTD
01/26/2016
Australia · Anesthesiology; Cardiovascular; Dental
Telectronics Pty., Ltd.
09/16/2009
Australia · Anesthesiology; Cardiovascular; Chemistry
Belgium Hospital Services N.V.
09/16/2009
Belgium · Set, Blood Transfusion
Laboratorios B. Braun S.A.
09/16/2009
Brazil · Physical Medicine
X12 Co., LTD.
04/05/2017
Bulgaria · Anesthesiology; Cardiovascular; Dental
Activa Brand Products, Inc.
09/16/2009
Canada · Injector, Fluid, Non-Electrically Powered
Aiken Enterprises
09/16/2009
Canada · Anesthesiology; Cardiovascular; Dental
Biosig Instruments Inc.
01/30/2019
Canada · Cardiovascular
Canix Sterilizer Inc.
09/16/2009
Canada · Anesthesiology; Cardiovascular; Dental
Cyex Medical Technologies Inc
09/16/2009
Canada · Anesthesiology; Cardiovascular; Dental
Gmp Inc
09/16/2009
Canada · Anesthesiology; Cardiovascular; Dental
Hedy Canada
09/16/2009
Canada · Glove, Patient Examination; Glove, Patient Examination, Latex
IND Diagnostic Inc.
02/25/2013
Canada · Anesthesiology; Cardiovascular; Dental
Med-Ex Diagnostics Of Canada, Inc.
09/16/2009
Canada · Anesthesiology; Cardiovascular; Dental
NIPRO CANADA CORPORATION
10/25/2018
Canada · Catheter, Hemodialysis, Implanted; Set, I.V. Fluid Transer
National Home Products Limited
09/16/2009
Canada · Anesthesiology; Cardiovascular; Dental
Progressive Chemical Research, Ltd.
09/16/2009
Canada · Anesthesiology; Cardiovascular; Dental
Shemberg Corp
09/16/2009
Canada · Anesthesiology; Cardiovascular; Dental
TREXO ROBOTICS HOLDINGS
07/02/2024
Canada · Physical Medicine
Trexo Robotics Holdings Inc.
07/02/2024
Canada · Physical Medicine
Tube Fab Ltd
09/16/2009
Canada · Anesthesiology; Cardiovascular; Dental
Ultrasoft Laboratories Ltd
09/16/2009
Canada · Lens, Contact (Other Material) - Daily
movingpeople.Net Canada, Inc.
02/07/2019
Canada · Vehicle, Motorized 3-Wheeled; Chair, Positioning, Electric
Beijing Unisoft Contact Lens Co., Ltd.
01/29/2019
China · Lenses, Soft Contact, Daily Wear; Lenses, Soft Contact, Extended Wear
Beyond Technology Corporation Nanchang
08/29/2016
China · Anesthesiology; Cardiovascular; Dental
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