Breathing circuit set, coaxial recallZ-2167-2025 · Hamilton Medical AG · initiated Jun 26, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hamilton Medical AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
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
Recall details
- Recall number
- Z-2167-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 26, 2025
- Posted by the FDA
- Jul 30, 2025
- Recalling firm
- Hamilton Medical AG
- Quantity
- 2,560
- Product code
- BZO
- 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 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.
Code information (models, lots, serial numbers)
UDI-DI: 07630002802963, Lots: 199675, 199676
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Breathing circuit set, coaxial 260128Hamilton Medical AG · Set, Tubing And Support, Ventilator (W Harness)2 recalls10 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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