CLASS I ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
Breathing circuit set, coaxial, 1.80 m, with flow sensor recalled
Hamilton Medical is recalling Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, distributed nationwide in the US. The recall was initiated on 26 Jun 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2167-2025
- FDA event ID
- 97222
- Recalling firm
- Hamilton Medical, Domat/Ems
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 26 Jun 2025
- FDA classified
- 30 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 26 Jun 2025 | Recall initiated by company | |
| 30 Jul 2025 | Classified by FDA | +34 days |
| 6 Aug 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArizonaColoradoConnecticutGeorgiaIllinoisIndianaMassachusettsMaineMissouriNorth CarolinaNew HampshireNew JerseyNew MexicoNew YorkOregonPennsylvaniaSouth CarolinaSouth DakotaTennesseeTexas
Questions about this recall
Why was it 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.
Which lots are affected?
UDI-DI: 07630002802963, Lots: 199675, 199676
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hamilton Medical
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | IntelliCuff, Portable automatic cuff pressure controller recalled | Hamilton Medical | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Hamilton C6 recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Ventilator Hamilton-C6, PN recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |
| Device | CLASS I | Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator recalled | Hamilton Medical | Packaging Defects | Nationwide |
Other CPAP & Ventilators recalls
All 554| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |