In Japan, when a medical device recall occurs, there is an obligation to immediately publicize it.
The PMDA (Pharmaceuticals and Medical Devices Agency), an agency affiliated with the MHLW (Ministry of Health, Labor and Welfare), is in charge of public announcements.
New Arrivals List
Unicell DxI800 System
Immunoluminescence Assay
Beckman Coulter Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12626
NES Medical Database[2-12626]
Tego Connector
Accessory Set for Blood Transfusion & Catheter
ICU Medical Japan K.K.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12628
NES Medical Database[2-12628]
EndoWrist Monopoly Line Instrument
Reusable Endoscopic Active Instrument for Radiofrequency Procedure
Intuitive Surgical LLC
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12632
NES Medical Database[2-12632]
EndoWrist Instrument
Reusable Active Procedure Instrument for Endoscope
Intuitive Surgical LLC
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12632
NES Medical Database[2-12632]
Acrivatrinova Pro Toric
Multifocal posterior chamber lens
Wakamoto Pharmaceutical Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12634
NES Medical Database[2-12634]
Intraocular Illumination Probe
Optical Fiber Surgery Illuminator
MORIA JAPAN Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12635
NES Medical Database[2-12635]
RET-700 Viewer
None
Rectam Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12636
NES Medical Database[2-12636]
APTUS Foot System/APTUS Ankle Trauma Anatomical Trilock Plate
Plate for Internal Fixation
Medatis Corporation
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12637
NES Medical Database[2-12637]
Brevera Breast Biopsy System
Aspiration Tissue Biopsy Needle Kit
Hologic Japan K.K.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12644
NES Medical Database[2-12644]
InterSurgical Heating Humidifier InterActive
Heating Humidifier
MC Medical Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12645
NES Medical Database[2-12645]
Ambulance van C
Emergency adhesive plaster
Shinya Co., Ltd. https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12646
NES Medical Database[2-12646]
Q GUIDANCE Platform
Neurosurgical Navigation Unit
Japan Stryker Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12647
NES Medical Database[2-12647]
Exact Cold Snare-STE
Single-use endoscopic non-active procedure device for spontaneous opening
Stellis Japan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12648
NES Medical Database[2-12648]
KSK Dental Dam
Dental Rubber Dam
Dentec Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12649
NES Medical Database[2-12649]
Thunderbeat Type S
Active Instruments for Multiple Energy Treatment
Olympus Medical Systems Co., Ltd.
Hachioji Plant
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12650
NES Medical Database[2-12650]
Surgical Tissue Management System
Ultrasound Surgical Equipment
Olympus Medical Systems Inc.Hachioji
Plant https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12650
NES Medical Database[2-12650]
X-ray CT Combination Positron CT System Optima PET/CT 500, Discovery PET/CT 600
X-ray CT Combination Positron CT System
GE Healthcare Japan K.K.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12651 NES Medical Database[2-12651]
Swan Excel Wire
Catheter Guidewire
for Cardiac and Central Cardiovascular System
Orbex Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12653
NES Medical Database[2-12653]
Disposable 3-Lumen Papilotome V-System
Single-Use Endoscopic Active Instrument for Radiofrequency Procedure
Olympus Medical Systems Co., Ltd. Hachioji Plant
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12654
NES Medical Database［2-12654］
Safe Touch PSV Set with Lure Adapter
Single-Use Blood Collection Needle
Nipro Corporation
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12656
NES Medical Database[2-12656]
Ospica Relay Cable
for External Pacemaker Cable and Adapter for External Pacemaker
Heiwa Bussan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=3-3045
NES Medical Database[3-3045]
Hemocron Test Cartridge
Elapsed Time Timer for Coagulation Measurement
Heiwa & Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=3-3045
NES Medical Database[3-3045]
Escron iSense
Single-Use ECG Electrode
Heiwa Bussan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=3-3045
NES Medical Database[3-3045]
TwitchView Sensor
Body Surface Electromyography Electrode
Heiwa & Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=3-3046
NES Medical Database[3-3046]
TwitchView Sensor
Electrodes for Body Surface Electrical Stimulators
Heiwa Bussan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=3-3046
NES Medical Database[3-3046]
LI Plus G
Cardiac Catheter Introducer Kit
Biotronic Japan
Co., Ltd. https://www.info.pmda.go.jp/rgo/MainServlet?recallno=3-3047
NES Medical Database[3-3047]
Katena Examination Contact Lenses
Single-Use Examination Contact Lenses
Takagi Seiko Corporation https://www.info.pmda.go.jp/rgo/MainServlet?recallno=3-3049
NES Medical Database［3-3049］
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