Z-2463-2026Class I

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

Name: Z-2463-2026 Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and...
Creator: Hamilton Medical AG
Published: 2026-05-29
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2026-05-29 / Open, Classified / root cause: design

FDA source

Hamilton Medical AG began a recall of Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators on 2026-05-29. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2463-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-05-29
Posted: 2026-06-30
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.
Product code: BZO Set, Tubing And Support, Ventilator (W Harness)
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
Root cause tag: design
FDA 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. 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 [email protected] 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.
Quantity in commerce: 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.
Product codes and lots: REF/UDI-DI: 260127/07630002802956, 17630002802953; 260128/07630002802963, 17630002802960; 260167/07630002802970, 17630002802977; 260168/07630002802987, 17630002802984. Lot numbers between 200379 and 205050 (including both.)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2463-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2463-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-30

Product code BZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)