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  • Device 418
  • Manufacturer 426
  • Event 936
  • Implant 8
Recall of Navigation Medical Medical Condition
  • Type of Event
    Recall
  • Event ID
    936
  • Date
    2018-09-04
  • Event Country
    South Korea
  • Event Terminated Date
    2019-03-04
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    Number 17-4378
Recall of Chemical analyzer
  • Type of Event
    Recall
  • Event ID
    935
  • Date
    2018-09-04
  • Event Country
    South Korea
  • Event Terminated Date
    2019-03-04
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    Seoul 14-461
Recall of Extracorporeal medical electrode
  • Type of Event
    Recall
  • Event ID
    934
  • Date
    2018-08-30
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-28
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    Seoul 10-1624
Recall of Cardiopulmonary heat exchanger
  • Type of Event
    Recall
  • Event ID
    933
  • Date
    2018-08-28
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-28
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    Accepted 03-978
Recall of Electrode for reusable foot-operated electrosurgical instrument, electrode for reusable...
  • Type of Event
    Recall
  • Event ID
    932
  • Date
    2018-08-28
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-28
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    14-448, 14-2583
Recall of Hemoglobin staining test reagent, hemocyte staining test reagent
  • Type of Event
    Recall
  • Event ID
    931
  • Date
    2018-08-24
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-24
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    Seoul 14-1844, Seoul 14-1845
Recall of Secondary Healing Foam Wound Covers
  • Type of Event
    Recall
  • Event ID
    930
  • Date
    2018-08-21
  • Event Country
    South Korea
  • Event Terminated Date
    2018-11-21
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    Juhu 15-671
Recall of Dyeing reagent for cell and histopathology I, Dyeing reagent for cell and histopatholog...
  • Type of Event
    Recall
  • Event ID
    929
  • Date
    2018-08-16
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-16
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    Seoul Received 13-2881, Seoul Received 13-2859, Received 18-1092, Seoul Received 13-2855, Received 18-1090, Accepted 13-1275, Accepted 13-1832, Received 18-1081 , Su-in 12-2286
Recall of Automatic blood type determination device
  • Type of Event
    Recall
  • Event ID
    928
  • Date
    2018-09-04
  • Event Country
    South Korea
  • Event Terminated Date
    2019-03-04
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    Seoul 13-28
Recall of Digital diagnostic x-ray equipment, diagnostic x-ray equipment
  • Type of Event
    Recall
  • Event ID
    927
  • Date
    2018-08-16
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-16
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    Number 10-1159, Number 15-4088
Recall of Cardiopulmonary marker test reagent
  • Type of Event
    Recall
  • Event ID
    926
  • Date
    2018-08-16
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-16
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    Accepted 12-1612
Recall of Gas anesthesia, gas anesthesia, gas anesthesia
  • Type of Event
    Recall
  • Event ID
    925
  • Date
    2018-08-16
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-16
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    15-1550, 13-3629, and 17-398
Recall of Blood coagulation test reagent
  • Type of Event
    Recall
  • Event ID
    924
  • Date
    2018-08-10
  • Event Country
    South Korea
  • Event Terminated Date
    2018-11-24
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    No. 16-599
Recall of Non-transplantable blood vessel connection container, non-transfusion type blood vessel...
  • Type of Event
    Recall
  • Event ID
    923
  • Date
    2018-08-13
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-13
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    Su-in 08-486, Su-in 03-839, Su-in 08-546
Recall of Medical chemical sterilizer
  • Type of Event
    Recall
  • Event ID
    922
  • Date
    2018-08-10
  • Event Country
    South Korea
  • Event Terminated Date
    2018-10-12
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    No. 13-2361
Recall of Electroencephalogram
  • Type of Event
    Recall
  • Event ID
    921
  • Date
    2018-08-10
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-10
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    Suh 08-1160
Recall of Measuring instruments of immunoassay for medical use, Measuring instruments of immunoas...
  • Type of Event
    Recall
  • Event ID
    920
  • Date
    2018-08-07
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-07
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    12-2224 in Seoul, 12-2229 in Seoul
Recall of Bone marrow intrinsic rod
  • Type of Event
    Recall
  • Event ID
    919
  • Date
    2018-08-07
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-07
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    No. 16-583
Recall of Blood gas analysis and electrolyte test reagents
  • Type of Event
    Recall
  • Event ID
    918
  • Date
    2018-08-07
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-07
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    Su-in 14-88
Recall of X-ray fluoroscopy for stationary digital circulators, X-ray fluoroscopy for stationary ...
  • Type of Event
    Recall
  • Event ID
    917
  • Date
    2018-08-07
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-07
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    13-1969, 13-1971, 14-2146, and 16-327
Recall of Medical gloves
  • Type of Event
    Recall
  • Event ID
    916
  • Date
    2018-08-06
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-06
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    Seoul 13-712
Recall of Special material Fracture joint plate
  • Type of Event
    Recall
  • Event ID
    915
  • Date
    2018-08-06
  • Event Country
    South Korea
  • Event Terminated Date
    2018-11-20
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    No. 12-1706
Recall of Automation System Robot Surgical Machine
  • Type of Event
    Recall
  • Event ID
    914
  • Date
    2018-08-06
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-06
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    No. 11-821
Recall of X-ray fluoroscopy for stationary digital circulators, angiographic X-ray apparatus
  • Type of Event
    Recall
  • Event ID
    913
  • Date
    2018-08-01
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-01
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    No. 08-349, No. 01-1414
Recall of Blood coagulation test reagent
  • Type of Event
    Recall
  • Event ID
    912
  • Date
    2018-08-06
  • Event Country
    South Korea
  • Event Terminated Date
    2019-02-06
  • Event Source
    KFDA
  • Event Source URL
    https://emed.mfds.go.kr
  • Notes / Alerts
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Extra notes in the data
    Accepted 12-2369
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About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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