Vyaire Medical, Inc. Leibnizstr. 7 Hochberg Germany 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Vyaire Medical, Inc. Leibnizstr. 7 Hochberg Germany
Lot Codes / Batch Numbers
UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.
Products Sold
UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.
Vyaire Medical, Inc. Leibnizstr. 7 Hochberg Germany is recalling Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample due to Potential of the nozzle separating during patient use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential of the nozzle separating during patient use.
Recommended Action
Per FDA guidance
Vyaire Medical issued an URGENT Field Safety Notice to its consignees on 04/08/2024 via email. The notice explained the issue, requested a pull out test for all affected devices to verify the adhesive is adequate prior to use. If the product was further distributed, the party distributing device was directed to notify those to whom the device was sent. For any additional questions or concerns, please contact Vyaire at GMBEMEA- FSCA-RDX-INTL@Vyaire.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026