Severity
Moderate
FDA Devices recall · Reported June 6, 2018
There is a potential for the cord to spark and cause a fire.
Gyrus Acmi, Incorporated recalled Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (008… - a moderate-severity action.
Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (008… was recalled by Gyrus Acmi, Incorporated in June 6, 2018. Reason: There is a potential for the cord to spark and cause a fire.. Check the official notice for the remedy. Verify recall #Z-1952-2018 with the FDA Devices before acting.
The recall
Gyrus Acmi, Incorporated issued this moderate-severity FDA Devices recall-There is a potential for the cord to spark and cause a fire..
Sourced from official FDA Devices enforcement records. Verify recall #Z-1952-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1952-2018) was formally reported on June 6, 2018, with the manufacturer initiating the action on April 17, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Gyrus Acmi, Incorporated is listed as the recalling firm, operating out of Southborough, MA. Federal records list the affected scope as 6447.
The documented reason for this recall is: There is a potential for the cord to spark and cause a fire. Distribution data in the federal record shows the product reached: 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,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
6447
Related Recalls
6
3 from same agency
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.
There is a potential for the cord to spark and cause a fire.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1952-2018 |
| Date reported | June 6, 2018 |
| Date initiated | April 17, 2018 |
| Recalling firm | Gyrus Acmi, Incorporated |
| Firm location | Southborough, MA |
| Affected scope | 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,… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 6, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.