Hamilton Medical AG: Medical Device Recall in 2025 - (Recall #: Z-2167-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class I

Date Initiated: June 26, 2025
Date Posted: August 6, 2025
Recall Number: Z-2167-2025
Event ID: 97222
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.

Status: Ongoing
Product Quantity: 2,560
Code Information:

UDI-DI: 07630002802963, Lots: 199675, 199676

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated