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.
FDA Recall Z-2167-2025 · Posted 2025-07-30
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Recalling FirmHamilton Medical AG
Recall StatusOpen, Classified
Product CodeBZO
Date Initiated2025-06-26
Product Quantity2,560
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.
Firm 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
Root Cause
Process control
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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