Reported Aug 6, 2025 · Ongoing

Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1,…

Hamilton Medical AG

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hamilton Medical AG · Parc Industrial Vial 10 · Domat/Ems · N/A

Is this the product you have?

  • 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
Lot codes and dates
  • UDI-DI07630002802963
  • Lots
    • 199675
    • 199676
Amount recalled
2,560

Where it was sold

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:21 PM UTC

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