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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66423

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

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Event summary

Timeline bucket
October 01, 2013
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Helix Medical LLC

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

Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3

Z-0128-2014
Recall number
Z-0128-2014
Initiated
October 01, 2013
Classification
Class III
Status
Terminated
Recalling firm
Helix Medical LLC
Quantity
47 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATSV II Valve product cannot be used as intended without the product body.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATSV II Valve product cannot be used as intended without the product body.

Code information

LOTS: 1057760, 1057919 and 1059222

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.