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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

Hamilton Medical Ventilator Breathing Circuits Recalled for Tubing Cracks

Agency Publication Date: July 30, 2025
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Summary

Hamilton Medical AG has recalled 2,560 coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON-T1, and HAMILTON-MR1 ventilators due to reports of cracks in the blue fresh gas delivery tubing. The recall affects 1.80 m circuit sets (REF: 260128) from lots 199675 and 199676. These cracks can compromise airflow and cause patients to rebreathe exhaled gases, posing a serious respiratory risk. No injuries have been reported to date.

Risk

Cracks in the breathing circuit tubing can prevent the proper delivery of fresh oxygen and cause patients to breathe back in their own exhaled carbon dioxide. This can lead to acute hypercapnia (high CO2 in the blood), respiratory acidosis, and potentially severe organ dysfunction if the issue is not recognized quickly.

What You Should Do

  1. This recall affects Hamilton Medical coaxial breathing circuit sets (1.80 m) with flow sensors and expiratory valve sets, identified as REF: 260128.
  2. Identify affected units by checking the packaging for lot numbers 199675 or 199676 and UDI-DI 07630002802963.
  3. Stop using the recalled breathing circuits immediately and remove them from your inventory.
  4. Contact Hamilton Medical AG or your authorized distributor to arrange for the return, replacement, or correction of the affected equipment.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set
Variants: 1.80 m length, Includes flow sensor, Includes expiratory valve set
Model / REF:
260128
Lot Numbers:
199675
199676
UDI:
07630002802963

Used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97222
Status: Active
Manufacturer: Hamilton Medical AG
Sold By: Hamilton Medical AG distributors
Manufactured In: Switzerland
Units Affected: 2,560
Distributed To: New Hampshire, New York, Connecticut, Pennsylvania, Illinois, Maine, Colorado, North Carolina, New Jersey, Utah, Texas, Georgia, South Carolina, Virginia, Indiana, South Dakota, Missouri, Oregon, Tennessee, Massachusetts, Arizona, New Mexico

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.