RegWardenFDA facility compliance records
Company

CADWELL INDUSTRIES, INC.

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2024: 2 recalls20172018201920202021202220232202420252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2024-05-17
    Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
  • Class IIOngoing2024-04-23
    There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “CADWELL INDUSTRIES, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-3020018-cadwell-industries-inc/

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