King Systems Corp. dba Ambu, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 11 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 8
- Compliance Actions
- 3
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0270-2025 | Class II | KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provi | September 26, 2024 |
| Z-0276-2025 | Class II | KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mou | September 26, 2024 |
| Z-0272-2025 | Class II | KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to pr | September 26, 2024 |
| Z-0271-2025 | Class II | KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provi | September 26, 2024 |
| Z-0275-2025 | Class II | KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth | September 26, 2024 |
| Z-0274-2025 | Class II | KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth | September 26, 2024 |
| Z-0273-2025 | Class II | KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth | September 26, 2024 |
| Z-0269-2025 | Class II | AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mo | September 26, 2024 |
| Z-0916-2020 | Class I | King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper air | November 5, 2019 |
| Z-1681-2019 | Class II | King LTS-D Kit Size 1, Model Number KLTSD431 | January 4, 2019 |
| Z-0321-2018 | Class II | UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF411 | March 15, 2017 |