Breathing circuit set — Class I medical device recall Z-2167-2025
Ongoing recall by Hamilton Medical AG, reported 2025-08-06, distributed nationwide. Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to th
| Recall number | Z-2167-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hamilton Medical AG, Domat/Ems, Switzerland |
| Recall initiated | 2025-06-26 |
| Classified | 2025-07-30 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 2,560 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 07630002802963 |
| Lot numbers | 199675, 199676 |
| Model numbers | 260128 |
Product
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Reason for recall
Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.
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-2167-2025. 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.