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Forsure

FORSURE MEDICAL PRODUCTS LLC · Model 11210095 · UDI-DI 00815123012003

BTR Prescription

510(k) clearances

19,094

Adverse events (256 deaths)

226

Recalls

132

Facilities

Description

A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

Recalls

Date	Firm	Reason
2025-02-13	Smiths Medical ASD, Inc.	Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulm
2024-02-26	MEDLINE INDUSTRIES, LP - Northfield	Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inf
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25	TELEFLEX LLC	Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

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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.