CLASS I ONGOING Device recall · Reported 15 May 2024 · FDA Enforcement Report
GmbH, Vyaire Twin Tube sample line recalled by Vyaire Medical
Vyaire Medical is recalling GmbH, Vyaire Twin Tube sample line, distributed nationwide in the US. The recall was initiated on 8 Apr 2024 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-1730-2024
- FDA event ID
- 94256
- Recalling firm
- Vyaire Medical, Hochberg, N/A
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 8 Apr 2024
- FDA classified
- 8 May 2024
- Reported
- 15 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 8 Apr 2024 | Recall initiated by company | |
| 8 May 2024 | Classified by FDA | +30 days |
| 15 May 2024 | 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
Potential of the nozzle separating during patient use.
Product as listed by the FDA
Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study.
Where it was distributed
US nationwide distribution.
Questions about this recall
Why was it recalled?
Potential of the nozzle separating during patient use.
Which lots are affected?
UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.
Where was it sold?
US nationwide distribution.
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.
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