Hamilton Medical AG medical device recall: Breathing circuit set
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99028
- Recall initiated
- May 29, 2026
- Classified by FDA
- Jun 30, 2026
- Posted in Enforcement Report
- Jul 8, 2026
- Recalling firm
- Hamilton Medical AG
- Firm location
- Domat/Ems, Switzerland
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on May 29, 2026. FDA classified it 32 days later, on Jun 30, 2026. Distribution reported by FDA: 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. Hamilton Medical AG has 12 recalls in our records.
Recalled products (1)
Z-2463-2026 Class I Ongoing
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Codes / lots: REF/UDI-DI: 260127/07630002802956, 17630002802953; 260128/07630002802963, 17630002802960; 260167/07630002802970, 17630002802977; 260168/07630002802987, 17630002802984. Lot numbers between 200379 and 205050 (including both.)
Quantity: 27,270 pcs
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 99028
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.