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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69446

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

Open FDA event record

Event summary

Timeline bucket
September 13, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
CooperSurgical, Inc. D.B.A. Lone Star Medical Products

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

Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.

Z-0147-2015
Recall number
Z-0147-2015
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Quantity
90 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
wrong package

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper.

Code information

Lots 149460 and 149911

Distribution pattern

Worldwide Distribution: US (nationwide) to North Carolina; and Internationally to Australia and Italy.