FDA Medical devices recall ·
Breathing circuit set, coaxial recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2463-2026
- Date
- (initiated May 29, 2026)
- Company / brand
- Hamilton Medical AG
Parc Industrial Vial 10, Domat/Ems, N/A, Switzerland - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 27,270 pcs
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Why was it recalled?
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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Maine Michigan Minnesota Missouri North Dakota Nebraska New Hampshire New Jersey New Mexico New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2463-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.