Breathing Circuit Set Recall: Hamilton Medical, Inc. Removes Coaxial Breathing Circuit Set Due to Possible Inner Blue Tube Cracks That May Impact Ventilation

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it

Affected Product

What to Do

Do not use any breathing circuits from affected lots. Replace any affected breathing circuits in use with patients and discard the affected circuit.

On June 27, 2025, Hamilton Medical, Inc. sent all affected customers an Urgent Medical Device Recall notice recommending the following actions: 

• Review breathing circuit inventory. 
• Stop use and quarantine any affected product.
• Replace any affected breathing circuit that is in use with a patient and discard the used affected circuit.
• Post the notice anywhere product may be stored.
• Contact the firm to arrange for product return.
• Return any units from the affected lot numbers to Hamilton Medical, Inc. with clearly marked outer packaging including the word “RECALL”.
• Distributors should forward the notice to any organization where potentially affected product has been transferred.
• Sign and return the acknowledgement form included with the letter.

Reason for Recall

Hamilton Medical, Inc. is recalling certain lots of coaxial breathing sets due to a quality issue involving a defective blade in the tube-cutting stage of production that may lead to a crack in the inner blue limb of the circuit. The inner blue limb delivers fresh gas to the patient while the outer limb carries away exhaled gas. If leakage occurs from a crack in the blue limb, the separation between inspiratory and expiratory flows becomes compromised. This can lead to the partial or complete rebreathing of exhaled gases.

The use of affected product may cause serious adverse health consequences, including acute buildup of carbon dioxide (hypercapnia) that the body can’t remove (respiratory acidosis). If the problem goes unrecognized, it may cause organ dysfunction and death. 

There have been no reported injuries or deaths related to this issue.

Device Use

Hamilton Medical, Inc. ventilator coaxial breathing circuits are intended to connect HAMILTON-C1/T1/MR1 ventilators to a patient tube or respiratory mask during ventilation.

Contact Information

Customers in the U.S. with questions about this recall should contact Hamilton Medical, Inc. at 800-426-6331 or [email protected].

Additional FDA Resources (listed in order of most to least recent):

• FDA’s Enforcement Report 
• Medical Device Recall Database

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

• How do I recognize a UDI on a label?  
• AccessGUDID database - Identify Your Medical Device  
• Benefits of a UDI System   

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.

Read the full alert.