Data Foundry

Medical device recalls 2018

Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators — Class II medical device recall Z-1952-2018

Terminated recall by Gyrus Acmi, Incorporated, reported 2018-06-06, distributed nationwide. There is a potential for the cord to spark and cause a fire.

Recall numberZ-1952-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmGyrus Acmi, Incorporated, Southborough, MA, United States
Recall initiated2018-04-17
Classified2018-05-29
Reported by FDA2018-06-06
Terminated2023-09-18
DistributedNationwide (US)
Countries outside the USAU, CA, JP, MX
Quantity6,447
UPC / GTIN / UDI-DI00821925008700
Model numbersC650-129A

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1952-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.