FDA Medical devices recall ·
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2167-2025
- Date
- (initiated June 26, 2025)
- Company / brand
- Hamilton Medical AG
Parc Industrial Vial 10, Domat/Ems, Switzerland - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 2,560
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 07630002802963, Lots: 199675, 199676
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.
States: Arizona Colorado Connecticut Georgia Illinois Indiana Massachusetts Maine Missouri North Carolina New Hampshire New Jersey New Mexico New York Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2167-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.