Use cautionMedical device recall · FDA · Published June 26, 2025
Hamilton Medical Breathing Circuit Recall: Crack Risk of Rebreathing Gases
Hamilton Medical recalls breathing circuits with possible blue tubing cracks that could cause rebreathing of exhaled gases, leading to respiratory issues. Affected units include specific model numbers and serial lots.
Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.
Take action
Contact the company
📍Recalling firmHamilton Medical AGParc Industrial Vial 10 · Domat/Ems, Switzerland
“Hamilton Medical Breathing Circuit Recall: Crack Risk of Rebreathing Gases.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51959-hamilton-medical-breathing-circuit-recall-crack-risk-of-rebreathing-gases. Based on FDA recall #Z-2167-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2167-2025%22&limit=1).
The FDA announced on June 26, 2025, that Hamilton Medical AG is recalling Breathing circuit sets used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators due to a crack in the blue tubing. The defect may lead to acute hypercapnia and organ dysfunction.
How to tell if you have it
Brand: Hamilton Medical
Product: Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set
REF: 260128
UDI-DI: 07630002802963
Lots: 199675, 199676
The hazard
According to the FDA, the ventilator coaxial breathing circuit may have a crack in the blue tubing used to deliver fresh gas. This compromise of inspiratory and expiratory flows could lead to partial or complete rebreathing of exhaled gases, resulting in acute hypercapnia, respiratory acidosis, and potential organ dysfunction.
Context
GovInfoNow's records show Hamilton Medical AG has 11 other recalls on record since March 9, 2018. Other recent recalls include the Breathing Circuit Sets Risk: Exhalation Obstruction During Ventilation (May 29, 2026), IntelliCuff Recall: Cuff System Leakage Error Risk (May 22, 2026), and Hamilton C6 Ventilator Recall: PCB Defect May Cause Ventilation Interruption (June 3, 2025). Other recent recalls of similar products include Draeger ErgoStar CM 60 Airway Connector Recall: Hose Cracks Risk Injury (Nov. 10, 2025), Medline Hudson RCI Breathing Circuits Recall: Risk of Infant Respiratory Failure (July 13, 2026), and Baxter Blue Ventilator Adapter Module Recall: Oxygen Desaturation Risk (Feb. 18, 2026).
How to tell if you have this one
Check for the reference number 260128 on the breathing circuit set. Affected units were sold with Hamilton C1, T1, or MR1 ventilators and have serial lots 199675 or 199676.
Brand
Hamilton Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Crack
Inspect the blue tubing for cracks or damage. If found, stop using the circuit immediately.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 22 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of NH, NY, CT, PA, IL, ME, CO, NC, NJ, UT, TX, GA, SC, VA, IN, SD, MO, OR, TN, MA, AZ, NM.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Colorado, Connecticut, Georgia, Illinois, Indiana, Maine, Massachusetts, Missouri, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2167-2025 (June 26, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2167-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.