Airway, Oropharyngeal, Anesthesiology
FDA adverse event reports and recall history for airway, oropharyngeal, anesthesiology (product code CAE), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 1,588
- Deaths
- 39
- Injuries
- 350
- Malfunctions
- 1,164
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-08-14Open, ClassifiedProcess control
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Devices could potentially be occluded or partially occluded.
- 2026-08-14Open, ClassifiedProcess control
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Devices could potentially be occluded or partially occluded.
- 2026-07-31Open, ClassifiedComponent design/selection
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
- 2025-08-06Open, ClassifiedProcess control
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
- 2025-08-06Open, ClassifiedProcess control
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
- 2024-10-30Open, ClassifiedNo Marketing Application
AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420
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.
- 2024-10-30Open, ClassifiedNo Marketing Application
KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421
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.
- 2024-10-30Open, ClassifiedNo Marketing Application
KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422
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.
- 2024-10-30Open, ClassifiedNo Marketing Application
KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
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.
- 2024-10-30Open, ClassifiedNo Marketing Application
KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430
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.
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