Use cautionMedical device recall · FDA · Published May 29, 2026
Hamilton Medical Breathing Circuit Sets Risk: Exhalation Obstruction During Ventilation
Hamilton Medical recalls coaxial breathing circuit sets (REFs 260127-260168) used with C1/T1/MR1 ventilators. Membranes may stick to valves, causing exhalation obstruction and oxygen desaturation if not tested before use.
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement
Take action
Contact the company
📍Recalling firmHamilton Medical AGParc Industrial Vial 10 · Domat/Ems, Switzerland
“Hamilton Medical Breathing Circuit Sets Risk: Exhalation Obstruction During Ventilation.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49054-hamilton-medical-breathing-circuit-sets-risk-exhalation-obstruction-during-ventilation. Based on FDA recall #Z-2463-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2463-2026%22&limit=1).
The FDA announced on May 29, 2026, that Hamilton Medical AG is voluntarily recalling Breathing circuit sets (REFs 260127, 260128, 260167, 260168) due to expiratory valve membrane adhesion risks. This defect may cause inadequate ventilation and oxygen desaturation.
How to tell if you have it
Brand: Hamilton Medical
Product: Breathing circuit set, coaxial
REFs: 260127, 260128, 260167, 260168
Lot numbers: 200379 through 205050
Used with: HAMILTON-C1, HAMILTON-T1, and HAMILTON-MR1 ventilators
The hazard
The ventilator coaxial breathing circuit may have expiratory valve sets with membranes sticking to the valve body. This issue is not detectable during pre-operative tests and may result in an "exhalation obstructed" alarm, leading to inadequate ventilation and oxygen desaturation.
Context
GovInfoNow's records show Hamilton Medical AG has issued 11 other recalls since March 9, 2018. Recent brand recalls include a May 22, 2026 IntelliCuff recall for leakage errors and June 26, 2025 breathing circuit recalls for crack risks. Other recent recalls of similar products include Medline Hudson RCI Breathing Circuits (July 13, 2026) and Medline Airway Exam Kit (Feb. 16, 2026).
How to tell if you have this one
Check for reference numbers 260127, 260128, 260167, or 260168 on the breathing circuit set. These sets are used with Hamilton C1, T1, or MR1 ventilators. Lot numbers between 200379 and 205050 (inclusive) are affected.
Brand
Hamilton Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Test Lung Action Before Use
Perform a pre-use test to check for exhalation obstruction. If the alarm occurs, remove the expiratory valve set to overcome membrane adhesion.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 42 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of KS, WA, VT, TX, WI, AR, OH, PA, CA, CO, ID, AZ, ME, MO, MI, IL, OR, VA, FL, NJ, SD, NY, NM, TN, CT, NE, OK, AL, GA, KY, NH, WY, ND, IN, UT, WV, DE, IA, PR, MN, LA, AK, HI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Michigan, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 40 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-2463-2026 (May 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2463-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.