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

FDA device recall Z-2463-2026 · posted 2026-06-30 · Open, Classified

Recall details

Recalling firm

Hamilton Medical AG

Reason for recall

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

Action taken

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. 3) You may continue to use breathing circuit sets, coaxial with lot numbers mentioned above according to their labelling. Mitigate potential risks by following the actions described in point "Type of Action to mitigate the risk." 4) Contact firm if during ventilation or testing an "exhalation obstructed" alarm occurs, replace the breathing circuit set as needed. - Firm will stay in close contact with the users and provide alternative solutions. - See notice for steps that can be taken to overcome membrane adhesion. 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. Type of Action to mitigate the risk To mitigate the risk associated with a potentially adhesive expiratory valve membrane, the user is advised to verify unimpeded expiratory gas flow prior to use. After performing the pre-operative test, ventilate a test lung using the following settings: Mode: PCV+ PEEP: 5 mbar Pcontrol: 5 mbar TI: 1 s Rate: 12 b/min If no "exhalation obstructed" alarm is issued, the expiratory valve is safe to use. If the "exhalation obstructed" alarm is triggered, do not use the breathing circuit set, coaxial. The breathing circuit set, coaxial must be discarded and replaced. Please contact Hamilton Medical Inc if this occurs.

Root cause

Component design/selection

Status

Open, Classified

Product code

BZO

Quantity affected

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

Date initiated

2026-05-29

Date posted

2026-06-30

Location

Domat/Ems, Switzerland