Recall Z-2463-2026 ยท BZO Set, Tubing And Support, Ventilator (W Harness)
Hamilton Medical AG
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
| Date | Jun 30, 2026 (initiated May 29, 2026) |
| Status | Open, Classified |
| 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 update |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.