# FDA recall Z-2167-2025

> **Hamilton Medical AG** · Class I · device recall initiated 2025-06-26.

## 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.

## Distribution

US Nationwide distribution in the states of NH, NY, CT, PA, IL, ME, CO, NC, NJ, UT, TX, GA, SC, VA, IN, SD, MO, OR, TN, MA, AZ, NM.

## Key facts

- **Recall number:** Z-2167-2025
- **Recalling firm:** Hamilton Medical AG
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-26
- **Report date:** 2025-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Domat/Ems, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2167-2025

## Citation

> AI Analytics. FDA recall Z-2167-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2167-2025. Source: US FDA. Licensed CC0.

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