Vyaire recallZ-1730-2024 · Vyaire Medical, Inc. · initiated Apr 8, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Vyaire Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential of the nozzle separating during patient use.
FDA root cause category: Process control
What the company is doing
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- [email protected].
Recall details
- Recall number
- Z-1730-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 8, 2024
- Posted by the FDA
- May 8, 2024
- Recalling firm
- Vyaire Medical, Inc.
- Quantity
- 649 devices
- Product code
- BZC
- FDA submissions
- K150810
- Distribution
- US nationwide distribution.
Product description
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.
Code information (models, lots, serial numbers)
UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vyaire V-707327Jaeger Medical GmbH · Calculator, Pulmonary Function Data1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K150810 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Vyntus V-707327Jaeger Medical GmbH · Calculator, Pulmonary Function Data1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page