FDA Issues Early Alert on November 10: Intersurgical Removes 22mm Smoothbore Breathing Tubes, Connectors May Detach, No Serious Injuries or Deaths Reported as of November 3
The Food and Drug Administration issued an Early Alert on November 10, 2026, stating that Intersurgical Inc. is removing certain 22mm Smoothbore breathing tubes and systems. The Center for Devices and Radiological Health described it as a potentially high-risk device issue and said the agency will update the page as significant new information becomes available. The alert was published at 1:53 p.m. on November 10.
The agency said Intersurgical has issued a letter to affected customers recommending that certain breathing systems be removed from where they are used or sold. Affected products include model 5018000, a 22mm Smoothbore tube with soft end connectors, 22F to 22F, at least 1.8 meters, with lot 32511811 listed in the alert product table.
The stated reason is that tetrahydrofuran solvent is used in manufacturing to bond the soft connectors onto the tube, and connectors may detach. The tubes and systems connect patients to machines that help them breathe, and detachment can cause ventilation loss and may cause brain damage or death, according to the alert summary.
The recommended action is to immediately stop using and quarantine affected lots and return affected product to Intersurgical. The company sent the letter to all affected customers on November 3, 2026. As of November 3, Intersurgical had reported no serious injuries or deaths associated with this issue.
Customers in the United States with adverse reactions, quality problems or questions may contact Intersurgical Customer Service at [email protected] or 800-828-9633, as listed in the alert. This report covers only the facts and contact resources in the agency alert and makes no individual treatment recommendation.
来源链接： https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-intersurgical-inc-removes-22mm-smoothbore-breathing-tubes-and-systems
Published by GSM · USA (original Chinese edition)
Photo: 食品药品监督固定图库（GSM asset-packs）
