FDA import alert
Import Alert 89-17
Detention Without Physical Examination of Medical Devices That Appear to Be Adulterated Because Their Quality Falls Below That Which They Purport or Are Represented to Possess
13
Red-list entries
0
Green-list entries
4
Countries
2026-04-01
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 13 of 13 entries — search a specific firm on the free checker.
- Eco-Med Pharmaceuticals, Inc.
11/30/2021
Canada · Media, Electroconductive; Transducer, Ultrasonic, Diagnostic; Media, Coupling, Ultrasound
- CARDICARE COMPANY LTD.
10/28/2021
China · System, Measurement, Blood-Pressure, Non-Invasive; Central venous blood pressure kit
- Cardicare Company, LTD
08/13/2020
China · System, Measurement, Blood-Pressure, Non-Invasive; Central venous blood pressure kit
- HONSUN (NANTONG) Co., Ltd.
05/22/2019
China · Cuff, Blood-Pressure
China · Pad, Heating, Powered; Electric Blanket, Household ELF Products, Non-Medical
China · Pad, Heating, Powered; Electric Blanket, Household ELF Products, Non-Medical
- Wenzhou Bokang Instrument Co., Ltd.
11/14/2017
China · System, Measurement, Blood-Pressure, Non-Invasive; Cuff, Blood-Pressure
China · Pad, Heating, Powered; Electric Blanket, Household ELF Products, Non-Medical
Mexico · Tube, Feeding
- Productos Para El Cuidado De La Salud
10/22/2018
Mexico · Catheters, Suction, Tracheobronchial; Tubes, Gastrointestinal (And Accessories)
- GLORIOUS MERCANTILE CORPORATION
03/31/2026
Pakistan · Scissors, General Use, Surgical
- Glorious Mercantile Corp. Pvt. Ltd.
03/31/2026
Pakistan · Scissors, General Use, Surgical
- Quality Concept (Pvt) Ltd.
04/01/2026
Pakistan · Retractor, All Types; Retractor, Surgical, General & Plastic Surgery; Scissors, General Use, Surgical
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