FDA Medical Device Recalls (openFDA)
Hamilton Medical AG: 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.
- Recall number
- Z-2167-2025
- 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.
- Status
- Open, Classified
- Initiated
- 2025-06-26
- Posted
- 2025-07-30
- Terminated
- not on file
- Reason
- 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
- 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 complaints@hamiltonmedical.com If you have any questions contact firm at: complaints@hamiltonmedical.com and 800-426-6331
- Quantity
- 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.
- Lot, serial or model codes
- UDI-DI: 07630002802963, Lots: 199675, 199676
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BZO
- Firm FEI
- 3014766741
- Firm city
- Domat/Ems
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28