Intersurgical Removes 22mm Smoothbore Breathing Systems Over Disconnection Risk
The US FDA has issued an early alert regarding Intersurgical Inc.'s removal of select lots of 22mm Smoothbore breathing tubes and systems. These devices connect patients to mechanical ventilators and breathing equipment to supply oxygen and air while allowing exhalation.
The action follows reports outside the United States of soft connectors detaching from the Smoothbore tubes. An investigation revealed that certain lots were manufactured with insufficient Tetrahydrofuran solvent to secure the bond. Detachment during clinical use can cause sudden compromised or lost ventilation, creating a risk of rapid desaturation, hypoxic brain damage, organ failure, or death. No serious injuries or fatalities had been reported as of November 3, 2026.
Healthcare providers and distributors are instructed to immediately stop using the affected product lots, quarantine remaining stock, and return affected units to the manufacturer. Facilities must also alert internal teams that operate respiratory equipment.
Key points
- Intersurgical is removing specific lots of 22mm Smoothbore breathing tubes and systems due to weak connector bonding.
- Manufacturing deficits involving insufficient solvent allow soft end connectors to detach from the breathing tube.
- Disconnection during mechanical ventilation can lead to acute hypoxia, brain injury, or death if not quickly resolved.
- Healthcare facilities must quarantine all affected lots immediately and return them to the supplier.
What it means for you
Intensive care, anesthesia, and biomedical teams in Pakistan should inspect respiratory inventory to determine whether any recalled Intersurgical 22mm Smoothbore lots are present in their facilities. Suspect lots should be quarantined immediately in line with the manufacturer's instructions. Clinicians and procurement officers should consult DRAP for local alerts and report any device malfunctions or detachment incidents.
Early Alert: Intersurgical Inc. Removes 22mm Smoothbore breathing tubes and systems
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.