Ventilator breathing circuit sets may obstruct exhalation valve
Hamilton Medical AG is recalling coaxial breathing circuit sets used with three ventilator models because membranes may stick to the expiratory valve body, preventing proper gas exhalation and potentially causing inadequate ventilation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall. The hazard involves a structural/functional defect in a critical life-support device (ventilator circuit) that could result in inadequate ventilation and oxygen desaturation, creating significant risk of serious injury or death per the rubric criterion for FDA Class I recalls.
Plain-English summary
Hamilton Medical AG is recalling coaxial breathing circuit sets with reference numbers 260127, 260128, 260167, and 260168. These circuits are used with HAMILTON-C1, HAMILTON-T1, and HAMILTON-MR1 ventilators. The membranes in the expiratory valve sets may stick to the valve body in a way that is not detectable during normal pre-operative testing.
When the membrane adheres to the valve, the ventilator will display an "exhalation obstructed" alarm. This obstruction may result in inadequate ventilation and oxygen desaturation in the patient. The problem cannot be reliably detected before use.
Approximately 27,270 units have been distributed nationwide. Affected lot numbers range from 200379 to 205050 (inclusive).
Hamilton Medical AG advises healthcare providers to test lung action prior to each use of these circuits. If an "exhalation obstructed" alarm occurs, remove or replace the expiratory valve set to overcome the membrane adhesion.
The recalled product
- Product
- Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
- Manufacturer
- Hamilton Medical AG
- Hazard
- exhalation-obstruction
- inadequate-ventilation
- oxygen-desaturation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- REF/UDI-DI: 260127/07630002802956
- 17630002802953
- 260128/07630002802963
- 17630002802960
- 260167/07630002802970
- 17630002802977
- 260168/07630002802987
- 17630002802984. Lot numbers between 200379 and 205050 (including both.)
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereThyroid FNA Pack-RX Surgical Kit Recalled for Bacterial Contamination
FDA (Devices) · 2026-07-08
- ModerateMedline Lumbar Puncture Kit recalled for Lidocaine quality issues
FDA (Devices) · 2026-07-08
- ModerateCRE Wireguided Device Recall Due to Potential Sterile Packaging Breach
FDA (Devices) · 2026-07-08
- ModerateThoracentesis and Paracentesis Trays Recalled for Deficient Manufacturing
FDA (Devices) · 2026-07-08
- ModerateRadius VSM Disposable NIBP Cuff recalled for rough edges
FDA (Devices) · 2026-07-08