Intersurgical 22mm Smoothbore Breathing Tubes and Systems

The U.S. Food and Drug Administration (FDA) has issued an Early Alert concerning a potentially high-risk manufacturing defect affecting certain 22mm Smoothbore breathing tubes and systems manufactured by Intersurgical Inc.

The problem involves inadequate bonding between soft connectors and breathing tubes, creating the possibility that connectors could separate during clinical use. A disconnected breathing circuit could interrupt or compromise ventilation, potentially depriving patients of adequate oxygen. Depending on the patient’s condition and the time required to restore ventilation, the consequences could include brain damage, organ failure, or death.

As of November 3, 2026, Intersurgical had reported no serious injuries or deaths associated with the issue.

Which Products Are Affected?

The alert covers specific lots of 11 Intersurgical 22mm Smoothbore product configurations, including:

• Standard Smoothbore breathing tubes with soft end connectors.
• Single- and dual-heated-wire breathing systems.
• Breathing systems incorporating water traps and auto-fill chambers.
• Systems with monitoring lines and exhalation valves.
• Bilevel breathing systems incorporating CO₂ leak ports and filtration components.

These devices connect patients to respiratory equipment, carrying air and oxygen to the patient while allowing exhaled gases to flow out. The affected products are identified by specific reference and lot numbers. Healthcare facilities should verify both identifiers when reviewing inventory.

The complete affected-product and lot-number list is available in the FDA Early Alert.

Manufacturing Investigation Identifies Insufficient Solvent Bonding

According to FDA, Intersurgical received reports from markets outside the United States involving soft connectors separating from Smoothbore breathing tubes. The company subsequently investigated the issue and tested internal inventory. The investigation found that some products had been manufactured using insufficient quantities of tetrahydrofuran (THF), a solvent used to bond the soft connectors to the tubing.

Solvent bonding relies on controlled application of a solvent to create a secure connection between compatible polymer components. If the bonding process does not achieve adequate joint integrity, the connector may separate when subjected to forces encountered during normal handling or clinical use.

For respiratory circuits, maintaining a secure connection is essential because separation can immediately compromise the delivery of ventilation.

Potential Consequences for Patients

Patients receiving assisted ventilation may depend on a continuous, properly functioning breathing circuit to maintain adequate oxygenation. If a connector separates, the resulting interruption or reduction in ventilation can cause oxygen levels to fall.

The severity of injury depends on several factors, including the patient’s underlying condition, the extent of ventilation loss, how quickly the disconnection is detected, and the time required to restore ventilation. In severe cases, prolonged oxygen deprivation can result in irreversible neurological injury, organ failure, or death.

Although no serious injuries or deaths had been reported as of November 3, the potential consequences justify immediate removal of affected products.

Immediate Actions for Healthcare Facilities

On November 3, 2026, Intersurgical notified affected customers and recommended immediate action. Healthcare facilities and distributors should:

1. Immediately discontinue use of affected products.
2. Identify and quarantine inventory matching the affected reference and lot numbers.
3. Arrange for affected products to be returned to Intersurgical.
4. Distribute the notification to all relevant users within their facilities.
5. Notify downstream customers if affected products have been distributed.

Facilities should ensure that quarantined products cannot inadvertently return to clinical inventory.

Regulatory and Quality-System Implications

The reported defect illustrates the importance of controlling manufacturing processes that establish the integrity of critical device connections. For solvent-bonded medical-device components, relevant process considerations may include solvent quantity, application technique, material compatibility, environmental conditions, bonding time, and verification of joint strength.

Where product conformity cannot be fully verified through subsequent inspection and testing, process validation becomes particularly important. A thorough manufacturing investigation would typically examine whether process parameters were adequately established and controlled, whether production records identify potentially affected lots, and whether acceptance testing was capable of detecting insufficient bonding.

The reported findings also raise questions about the effectiveness of in-process controls and the methods used to verify connector integrity. These are appropriate areas for quality-system evaluation, not conclusions that FDA has reached concerning Intersurgical’s regulatory compliance.

The issue further demonstrates the importance of monitoring complaints and adverse events across international markets. Reports originating outside the United States prompted an investigation that identified potentially affected products in the U.S. market.

FDA Continues Its Review

FDA issued the notification through its Early Alert program, which informs healthcare providers and the public about potentially high-risk medical-device problems while the agency continues its evaluation. The alert should not be confused with a completed FDA recall classification. Intersurgical has already initiated customer notification and product-removal activities. FDA states that it will update the alert as significant new information becomes available.

Healthcare professionals and consumers may report suspected adverse events or device-quality problems through the FDA MedWatch reporting system.

For questions or assistance with affected products, customers may contact Intersurgical:

Email: recalls@intersurgicalinc.com
Telephone: 800-828-9633

A Critical Manufacturing Connection

Breathing circuits are essential components of respiratory support systems, and their safety depends on the integrity of every connection. The Intersurgical alert demonstrates how an apparently straightforward manufacturing operation—bonding a connector to a tube—can become a significant patient-safety concern when process controls fail to achieve the intended result.

For manufacturers, the broader lesson is that critical manufacturing characteristics must be adequately controlled and verified. For healthcare facilities, the immediate priority is ensuring that affected breathing systems are identified and removed from use.