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May 2025 Medical Device Recall Information (Japan) | NES

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

Midas Rex Legend Tool
Single-use orthopedic burr
Medtronic Japan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12303
MeKiKi Database [2-12303]

Shibuko BX2 needle guide
Ultrasound probe puncture kit
Century Medical Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12306
MeKiKi Database [2-12306]

Shibuko UP series needle guide
Ultrasound probe puncture kit
Century Medical Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12307
MeKiKi Database [2-12307]

AVVIGO System
Cardiovascular Ultrasound Diagnostic Imaging Device
Boston Scientific Japan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12309
MeKiKi Database[2-12309]

Merit Resolve Drainage Catheter Kit
Sterile indwelling drainage tubes and catheters
Merit Medical Japan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12311
MeKiKi Database[2-12311]

Dexcom G7 CGM System
Glucose Monitor
SystemDexCom Japan LLC
https://www.info.pmda.go.jp/rgo/MainServlet? recallno
=2-12312 MeKiKi Database[2-12312]

SN Unit Excellence
ENT treatment unit
Nagashima Medical Instruments Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12313
MeKiKi Database[2-12313]

Digital X-ray general-purpose radiography system RADspeed safire
Fixed-type digital general-purpose X-ray diagnostic device
Shimadzu Corporation
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12314
MeKiKi Database[2-12314]

Ceiling-mounted X-ray tube suspension CH-200
Ceiling-mounted X-ray tube support
Shimadzu Corporation
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12314
MeKiKi Database[2-12314]

Whole-body MR device Multiva 1.5T
superconducting magnet type whole body MR device
Philips Japan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12317
MeKiKi Database[2-12317]

Spectral CT 7500
Whole body X-ray CT diagnostic device
Philips Japan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12318
MeKiKi Database[2-12318]

Primeject
Disposable endoscopic injection needle
Lake R&D Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12319
MeKiKi Database[2-12319]

Drill
Surgical drill bit
Implatex Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12320
MeKiKi Database [2-12320]

OPTIMA Coil System
Prosthetic material for promoting embolization in blood vessels of the central circulatory system
Century Medical Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12321
MeKiKi Database [2-12321]

Constellation Surgical Pack
Disposable Class III Treatment Kit
Alcon Japan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12323
MeKiKi Database [2-12323]

Vitros XT7600
Discrete Type Clinical Chemistry Automated Analyzer
Ortho Clinical Diagnostics Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12324
MeKiKi Database [2-12324]

Vitros 3600
Immunoluminescence Measurement Device
Ortho Clinical Diagnostics Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12324
MeKiKi Database [2-12324]

Lucierite DL-702S
General-purpose Dental Illuminator
Takara Belmont Corporation Osaka Head Office
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12325
MeKiKi Database [2-12325]

Stryker Corporation Bone saw blades
Single-use surgical
saws Stryker Japan Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12327
MeKiKi Database[2-12327]

BNCT treatment system NeuCure
Neutron irradiation device for boron neutron capture therapy
Sumitomo Heavy Industries Ltd. Ehime Manufacturing Co., Ltd. Niihama Plant
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12330
MeKiKi Database[2-12330]

Whole-body X-ray CT diagnostic device SCENARIA View
Whole-body X-ray CT diagnostic device
FUJIFILM Corporation
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12331
MeKiKi Database[2-12331]

Welch Allyn Blood pressure monitor
Aneroid blood pressure monitor
Welch Allyn Japan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12332
MeKiKi Database[2-12332]

LX-1000 series ECG, respiration and SpO2 transmitter LX-1300
telemetry ECG transmitter
Fukuda Denshi Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12334
MeKiKi Database[2-12334]

Mimapro microwave ablation system
Microwave scalpel
Sugan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12335
MeKiKi Database[2-12335]

PP suture-K
polypropylene suture
Inc. Kono Manufacturing Co. , Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12336
MeKiKi Database [2-12336]

Newport Ventilator Model HT70
General-purpose ventilator
Covidien Japan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12338
MeKiKi Database [2-12338]

HTS Stella Plate System (sterilized)
Internal fixation screw
HOYA Technosurgical Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12339
MeKiKi Database [2-12339]

MEOCHECK
No
QD Laser Co., Ltd. 
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-12346
MeKiKi Database [2-12346]

 JBP Nanoneedle
Disposable injection needle
Japan Biologics Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=3-2984
MeKiKi Database[3-2984] 

Endoscopic examination support program EW10-EG01Endoscopic image diagnosis support program for lesion detection FUJIFILM Corporation
https://www.info.pmda.go.jp/rgo/MainServlet?recallno=3-2986
MeKiKi Database[3-2986




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