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CriticalClass IOngoing

FDA Devices recall · Reported May 15, 2024

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.

Potential of the nozzle separating during patient use.

Recall #
Z-1730-2024
Affected scope
649 devices
Initiated
April 8, 2024
Verify with FDA Devices →
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Vyaire Medical, Inc. recalled Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The Twin… - a critical-severity action.

Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The Twin… was recalled by Vyaire Medical, Inc. in May 15, 2024. Reason: Potential of the nozzle separating during patient use.. Check the official notice for the remedy. Verify recall #Z-1730-2024 with the FDA Devices before acting.

The recall

Vyaire Medical, Inc. issued this critical-severity FDA Devices recall-Potential of the nozzle separating during patient use..

Critical
severity level
649 units
affected scope
Class I
classification
May 15, 2024
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1730-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1730-2024) was formally reported on May 15, 2024, with the manufacturer initiating the action on April 8, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. Vyaire Medical, Inc. is listed as the recalling firm, operating out of Hochberg, N/A. Federal records list the affected scope as 649 devices.

The documented reason for this recall is: Potential of the nozzle separating during patient use. Distribution data in the federal record shows the product reached: US nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 40,322 medical devices recalls on record

-1,00001,0002,0003,0004,000 20052008201120142017202020232026 1,248
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Critical

Affected scope

649 devices

Related Recalls

6

3 from same agency

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.

Reason for recall

Potential of the nozzle separating during patient use.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Ongoing
Recall number Z-1730-2024
Date reported May 15, 2024
Date initiated April 8, 2024
Recalling firm Vyaire Medical, Inc.
Firm location Hochberg, N/A
Affected scope 649 devices
Distribution US nationwide distribution.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

649 devices units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1730-2024) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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.. Recalled by Vyaire Medical, Inc.. Units affected: 649 devices.
Why was this product recalled?
Potential of the nozzle separating during patient use.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 15, 2024. Severity: Critical. Recall number: Z-1730-2024.
Where was the recalled product distributed?
Distribution: US nationwide distribution..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-1730-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 15, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.