FDA Warns of Recall for Intersurgical Breathing Tubes Over Disconnection Risk

What was announced

The FDA MedWatch Safety Alerts program issued an Early Alert regarding certain Intersurgical 22mm Smoothbore breathing tubes and systems. The notice follows a letter sent by Intersurgical Inc. to affected customers on November 3, 2026. Intersurgical advised customers to immediately stop using, quarantine, and return affected product lots.

Intersurgical manufactures these tubes to connect patients to medical machines that supply air and oxygen. During production, workers use Tetrahydrofuran solvent to glue soft connectors onto the tubing. After receiving reports from international markets that soft connectors were detaching from tubes, Intersurgical tested its internal stock. The manufacturer discovered that some batches lacked enough solvent to form a secure connection.

The recall covers 11 product reference numbers, including specific lots of single and dual heated wire systems, bilevel systems, and breathing tubes with exhalation valves.

What it means

A disconnected breathing tube can stop or reduce the flow of oxygen to a patient. If a connector detaches while a machine is running, the patient may lose ventilation until medical staff intervene manually.

Depending on how long the interruption lasts and the condition of the patient, a drop in oxygen levels can cause severe complications. The FDA stated that severe oxygen loss could result in organ failure, brain damage, or death. As of November 3, 2026, Intersurgical reported zero serious injuries or deaths related to the defect.

Healthcare facilities using these devices must check their inventory against the listed lot numbers. Staff must isolate affected stock, return it to Intersurgical, and inform any customers who received the products. Anyone experiencing issues can contact Intersurgical customer service at 800-828-9633 or submit a report to the FDA MedWatch program.

What the announcement does not tell us

The alert does not state how many total units of breathing tubes are subject to the recall. It does not clarify how many medical facilities in the United States received the affected lots.

The document does not detail how long the manufacturing flaw existed before testing identified it. It also does not outline whether Intersurgical has produced replacement breathing systems to cover hospital shortages resulting from this recall. Finally, the FDA noted it is still reviewing information about the issue and has not published a final recall classification.