Z-2167-2025Class I

Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with...

Name: Z-2167-2025 Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with...
Creator: Hamilton Medical AG
Published: 2025-06-26
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2025-06-26 / Open, Classified / root cause: manufacturing process

FDA source

Hamilton Medical AG began a recall of 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 on 2025-06-26. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2167-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-06-26
Posted: 2025-07-30
Recalling firm: Hamilton Medical AG
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.
Product code: BZO Set, Tubing And Support, Ventilator (W Harness)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Starting on 6/26/2025, recall notices were emailed to customers who were asked to do the following: Return affected devices. If one of the affected breathing circuits would be already in use with a patient, it is requested to exchange it and discard the product after replacement. If you are a distributor, please forward to any organization where potentially affected product has been transferred. Complete and return the acknowledgement form via email to [email protected] If you have any questions contact firm at: [email protected] and 800-426-6331
Quantity in commerce: 2,560
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.
Product codes and lots: UDI-DI: 07630002802963, Lots: 199675, 199676

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2167-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2167-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-30

Product code BZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)