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King Systems Corp. Recalls
11 recalls on record · January 17, 2018 to November 6, 2024 · Medical Devices
Recalls by year
18
19
20
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
November 6, 2024Medical DevicesFDA
King Systems Corp. dba Ambu, Inc. recalls KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide paten
Hazard: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
November 6, 2024Medical DevicesFDA
King Systems Corp. dba Ambu, Inc. recalls KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent
Hazard: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
November 6, 2024Medical DevicesFDA
King Systems Corp. dba Ambu, Inc. recalls KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent
Hazard: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
November 6, 2024Medical DevicesFDA
King Systems Corp. dba Ambu, Inc. recalls KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent
Hazard: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
November 6, 2024Medical DevicesFDA
King Systems Corp. dba Ambu, Inc. recalls KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway
Hazard: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
November 6, 2024Medical DevicesFDA
King Systems Corp. dba Ambu, Inc. recalls KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway.
Hazard: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
November 6, 2024Medical DevicesFDA
King Systems Corp. dba Ambu, Inc. recalls KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway.
Hazard: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
November 6, 2024Medical DevicesFDA
King Systems Corp. dba Ambu, Inc. recalls AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide pate
Hazard: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
February 12, 2020Medical DevicesFDA
King Systems Corp. dba Ambu, Inc. recalls King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the p
Hazard: Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions.
June 5, 2019Medical DevicesFDA
King Systems Corp. dba Ambu, Inc. recalls King LTS-D Kit Size 1, Model Number KLTSD431
Hazard: Size 0 products were incorrectly packaged and labeled as a size 1 products.
January 17, 2018Medical DevicesFDA
King Systems Corp. dba Ambu, Inc. recalls UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, D
Hazard: Potential for leak test failures.