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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79762

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

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Event summary

Timeline bucket
April 17, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Gyrus Acmi, Incorporated

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

Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided non-sterile and are reusable. The cord is designed to be used with Gyrus ACMI GOCUS 640, Bovie, and other general purpose monopolar electrosurgical generators and appropriate electrodes and endoscopes.

Z-1952-2018
Recall number
Z-1952-2018
Initiated
April 17, 2018
Classification
Class II
Status
Terminated
Recalling firm
Gyrus Acmi, Incorporated
Quantity
6447

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the cord to spark and cause a fire.

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

There is a potential for the cord to spark and cause a fire.

Code information

All lots manufactured before December 7, 2017 UDI (00821925008700)

Distribution pattern

Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of : Japan, Canada, Mexico, Australia, and EU.