Home › Wm & Dg, Inc. › Big Mouth™ Oral Airway with Balloon
Big Mouth™ Oral Airway with Balloon
Wm & Dg, Inc. · Model OA4100 · UDI-DI 00850027063010
CAE
Prescription
10
510(k) clearances
1,598
Adverse events (39 deaths)
76
Recalls
230
Facilities
Description
The Big Mouth™ Oral Airway with Balloon is a single-use, non-sterile, 2-lumen channel, flexible device intended to be used for maintaining an open airway and facilitating intubation in airway management for adults > 55kg (121 lbs.)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-07 | INTEGRATED MEDCRAFT LLC | Devices could potentially contain an occluded or partially occluded Guedel Airway tip. |
| 2026-06-15 | Intersurgical Inc | Devices could potentially be occluded or partially occluded. |
| 2026-06-15 | Intersurgical Inc | Devices could potentially be occluded or partially occluded. |
| 2025-06-20 | Intersurgical Inc | Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and inf |
| 2025-06-20 | Intersurgical Inc | Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and inf |
| 2024-09-26 | King Systems Corp. dba Ambu, Inc. | 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. |
| 2024-09-26 | King Systems Corp. dba Ambu, Inc. | 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. |
| 2024-09-26 | King Systems Corp. dba Ambu, Inc. | 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. |
| 2024-09-26 | King Systems Corp. dba Ambu, Inc. | 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. |
| 2024-09-26 | King Systems Corp. dba Ambu, Inc. | 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.