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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62970

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

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Event summary

Timeline bucket
March 08, 2012
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 indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.

Z-2336-2012
Recall number
Z-2336-2012
Initiated
March 08, 2012
Classification
Class III
Status
Terminated
Recalling firm
Helix Medical LLC
Quantity
2 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

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Inspect official wording and provenance

Reason for recall

Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.

Code information

Lot#1008419

Distribution pattern

Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom