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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94256

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 08, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Vyaire Medical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1730-2024
Recall number
Z-1730-2024
Initiated
April 08, 2024
Classification
Class I
Status
Ongoing
Recalling firm
Vyaire Medical, Inc.
Quantity
649 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential of the nozzle separating during patient use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential of the nozzle separating during patient use.

Code information

UDI/DI 14250892903603, All lots prior to June 2023 or with a serial number before 04I00122 are potentially affected.

Distribution pattern

US nationwide distribution.