FreshRecalls

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 24, 2026 at 12:00 AM UTC.

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