Breathing circuit set — Class I medical device recall Z-2463-2026
Ongoing recall by Hamilton Medical AG, reported 2026-07-08, distributed nationwide. Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, no
| Recall number | Z-2463-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical AG, Domat/Ems, N/A, Switzerland |
| Recall initiated | 2026-05-29 |
| Classified | 2026-06-30 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 27,270 units |
| UPC / GTIN / UDI-DI | 07630002802956, 07630002802963, 07630002802970, 07630002802987, 17630002802953, 17630002802960, 17630002802977, 17630002802984 |
| Model numbers | 260127, 260128, 260167, 260168 |
Product
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2463-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.