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FDAClass I · Medical device · Recalled July 8, 2026
Breathing circuit set recall — Hamilton Medical AG
Hazard: 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
Class I: most serious — reasonable probability of serious health consequences or death.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2463-2026
- Brand
- Hamilton Medical AG
- Classification
- Class I
- Units affected
- 27,270 pcs
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Affected products
Companies & origin
- Recalling firm location
- Domat/Ems, N/A, Switzerland
- Firm address
- Parc Industrial Vial 10, N/A, N/A
Identifying details (verbatim from the notice)
- Product codes / lots
- REF/UDI-DI: 260127/07630002802956, 17630002802953; 260128/07630002802963, 17630002802960; 260167/07630002802970, 17630002802977; 260168/07630002802987, 17630002802984. Lot numbers between 200379 and 205050 (including both.)
- 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.
- Firm notified the public via
- Letter
- FDA event ID
- 99028
- Recall initiated
- May 29, 2026
- FDA classified
- June 30, 2026
- FDA report date
- July 8, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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