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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66533

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

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Event summary

Timeline bucket
September 10, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Aesculap, 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

Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.

Z-0479-2014
Recall number
Z-0479-2014
Initiated
September 10, 2013
Classification
Class II
Status
Terminated
Recalling firm
Aesculap, Inc.
Quantity
85

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.

Code information

all GN161's distributed between 4/28/2009 and 5/22/2013.

Distribution pattern

Worldwide Distribution - USA Nationwide and countries of: Austria, Germany, Japan, and Taiwan.