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HEADSTAR

HEADSTAR MEDICAL PRODUCTS CO., LTD. · Model HP-8040 · UDI-DI 04711402237012

CAE Prescription

510(k) clearances

1,590

Adverse events (39 deaths)

Recalls

230

Facilities

Description

Designed for maintaining unobstructed oropharyngeal airway during general anesthesia and in unconscious patients. smooth rounded edges minimize tissue trauma and robust bite block prevents occlusion. optional in white color or color coded. Geudal airway kit in full 8 sizes packed in one transparent case is available for easy carry and storage.

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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Data 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.