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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73660

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

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Event summary

Timeline bucket
March 18, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Boston Scientific Corporation

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

Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths

Z-1567-2016
Recall number
Z-1567-2016
Initiated
March 18, 2016
Classification
Class II
Status
Terminated
Quantity
4 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Mislabeled

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

Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm

Code information

Lot Number: 18876596 Exp Date: February 1, 201 8

Distribution pattern

Nationwide Distribution to AL, CA, MA, and TX.