Z-1952-2018Class II

Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The...

Name: Z-1952-2018 Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The...
Creator: Gyrus Acmi, Incorporated
Published: 2018-04-17
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2018-04-17 / Terminated / root cause: design

FDA source

Gyrus Acmi, Incorporated began a recall of Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire... on 2018-04-17. FDA classified it as Class II and gives the reason as "There is a potential for the cord to spark and cause a fire". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1952-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-17
Posted: 2018-05-29
Terminated: 2023-09-18
Recalling firm: Gyrus ACMI, Inc.
Product: 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.
Product code: FAS Electrode, Electrosurgical, Active, Urological
Reason for recall: There is a potential for the cord to spark and cause a fire.
Root cause tag: design
FDA root cause: Device Design
Action: Notification letters were distributed on April 17, 2018. The letters instruct customers to perform the following: Immediately assess any affected product you have in stock and replace the IFU with the revised IFU. Also ensure that any potential users of the devices are aware of the additional warning in the revised IFU. Future versions of the IFU will include the warning. Remove and discard all cords in use greater than one year. If you need additional copies of the IFU, call your Olympus customer service representative at 1-888-524-7266 to arrange for them to be provided. Please note on the enclosed Reply Form that you have received this information. Fax the completed Reply Form to 484-896-7128 regardless of whether you have any affected inventory at your facility. In addition, if you may have further distributed this product, please identify your customers, inform them at once of this action, provide the revised IFU and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this letter. For further questions, please call (508) 804-2600.
Quantity in commerce: 6447
Distribution: 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.
Product codes and lots: All lots manufactured before December 7, 2017 UDI (00821925008700)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1952-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1952-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-29

Product code FAS

K890328Class IIAdult ResectoscopeCircon Video / cleared 1990-02-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)