CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Intersurgical Inc. has issued a letter to affected customers recommending certain breathing systems be removed from where they are used or sold.
Affected devices:
| REF | Description | Product Lot Numbers |
|---|---|---|
| 5018000 | 22mm Smoothbore tube with soft end connectors, 22F-22F, ≥ 1.8m | 32511811 |
| 5025000 | 22mm Smoothbore single heated wire breathing system with water trap, ≥ 1.6m | 32522651 |
| 5025310 | 22mm Smoothbore single heated wire breathing system with water trap and auto-fill chamber, ≥ 1.6m | 32526115 |
| 5026000 | 22mm Smoothbore dual heated wire breathing system, ≥ 1.6m | 32525551 |
| 5183000 | 22mm Smoothbore breathing system with monitoring line and exhalation valve, ≥ 1.6m | 32527207 |
| 5191000 | 22mm Smoothbore breathing system with monitoring line and exhalation valve, single limb, 1.8m | 32520670, 32522190, 32522802 |
| 5191850 | 22mm Smoothbore exhalation valve heated wire breathing system with monitoring line and extra limb, ≥ 1.6m | 32521551, 32521655 |
| 5194850 | 22mm Smoothbore exhalation valve heated wire breathing system with extra limb, ≥ 1.6m | 32518127 |
| 5804000 | 22mm Smoothbore bilevel breathing system with swivel CO₂ leak port, ≥ 1.8m | 32508034, 32509327, 32510909, 32516895, 32518659, 32519175, 32525543 |
| 5805000 | 22mm Smoothbore bilevel breathing system with monitoring line and swivel CO₂ leak port, ≥ 1.6m | 32516315, 32517877 |
| 5805030 | 22mm Smoothbore bilevel breathing system with swivel CO₂ leak port and Clear-Guard Midi filter, ≥ 1.8m | 32505469, 32506841, 32513929, 32514276, 32515579, 32518484, 32519342, 32519468, 32519979, 32522143, 32522415, 32523651, 32525498, 32525628, 32526171, 32526270, 32527299, 32528409 |
What to Do
Immediately stop using and quarantine affected lots. Return affected product to Intersurgical.
On November 3, 2026, Intersurgical sent all affected customers a letter recommending the following actions:
- Immediately discontinue use and quarantine any stock with the affected product/lot numbers.
- Return affected product to Intersurgical.
- Share this notice with all users of these products within your facility. If you have distributed any of these products, please immediately contact your customers.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Intersurgical stated that during the manufacture of these products, Tetrahydrofuran (THF) solvent is used to bond the soft connectors onto the Smoothbore tube. Following reports from markets outside the U.S. of soft connectors disconnecting from the tube, an investigation and testing of internal stock found that some products were manufactured with too little solvent to ensure a secure connection.
If a connector disconnects from the Smoothbore tube during use, this could result in a loss of ventilation or compromised ventilation, which may cause the patient to desaturate until ventilation is manually re-initiated. Depending on the individual patient, the specific situation and the time to re-initiate ventilation, loss of ventilation could potentially lead to organ failure, brain damage or death caused by hypoxia.
As of November 3, 2026, Intersurgical has reported no serious injuries or deaths associated with this issue.
Device Use
Intersurgical 22mm Smoothbore breathing tubes and systems connect patients to machines that help them breathe. They carry air and oxygen to the patient and allow exhaled air to flow out.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Intersurgical Customer Service at [email protected] or 800-828-9633.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.