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Recall

Class II — Cadwell Industries Inc

Recalling firmCADWELL INDUSTRIES, INC.
Registered facilityCADWELL INDUSTRIES, INC. (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonElectroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
ProductCascade IOMAX Cortical Module, REF: 190296-200
Quantity26 units
DistributionUS: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom
Initiated2024-05-17
Classified2024-07-12
Recall numberZ-2349-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Cadwell Industries Inc (Z-2349-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94764/

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