Hamilton Medical AG: Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

Recall number

Z-2463-2026

Recalling firm

Hamilton Medical AG

Product

Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.

Status

Open, Classified

Initiated

2026-05-29

Posted

2026-06-30

Terminated

not on file

Reason

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

Root cause

Component design/selection

Action

On 5/29/2026, correction notices were emailed to customers who were asked to do the following: 1) Inform all potential users of affected devices within your facility about this issue. 2) Inform all affected end users and/or sub-distributors and provide them with this notice. 5) Post this notice to ensure all personnel are informed. 6) Complete and return Facility Reply Form via email to complaints@hamiltonmedical.com Customers with questions can contact the firm at the email above. Initially customers were informed to continue use and perform actions to mitigate risk, but later the updated notice called for affected device removal. On 7/8/2026, updated recall notices were emailed and mailed to healthcare facilities, physicians and end users who were informed of the following: 1) Discontinue use and quarantine affected devices. 2) Do not follow previous instructions for product modification. 3) Inform all affected end users and/or sub-distributors and provide them with this notice. 4) Contact firm if you have affected product in inventory. - Discard any affected product(s) and confirm destruction. Or - Contact Hamilton Medical for a return material authorization number and return label. -Contact your sales representative to acquire replacement product. 5) Complete and return the Facility Reply Form.

Quantity

27,270 pcs

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.

Lot, serial or model codes

REF/UDI-DI: 260127/07630002802956, 17630002802953; 260128/07630002802963, 17630002802960; 260167/07630002802970, 17630002802977; 260168/07630002802987, 17630002802984. Lot numbers between 200379 and 205050 (including both.)

510(k) numbers

not on file

PMA numbers

not on file

Product code

BZO

Firm FEI

3014766741

Firm city

Domat/Ems

Firm state

not on file

Firm country

Switzerland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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