Hamilton Medical Ag: Set, Tubing And Support, Ventilator (w Harness)
Hamilton Medical AG is recalling breathing circuit sets used with certain ventilator models (HAMILTON-C1, HAMILTON-T1, and HAMILTON-MR1) because the expiratory valve membranes may stick to the valve body in a way that cannot be detected before use, potentially causing an obstruction alarm and inadequate ventilation. The recall affects ventilator breathing circuit sets with specific reference numbers distributed nationwide across all U.S. states and territories. This is a Class I recall, the most serious classification.
- 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.
- 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
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-29
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/3eb9616b-1289-4e4c-9d6f-faa0ae7d93ef