Cascade IOMAX Cortical Module — Class II medical device recall Z-2349-2024

Ongoing recall by Cadwell Industries Inc, reported 2024-07-24, distributed in CA, IL. Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to

Recall number	`Z-2349-2024`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Cadwell Industries Inc, Kennewick, WA, United States
Recall initiated	2024-05-17
Classified	2024-07-12
Reported by FDA	2024-07-24
Distributed	CA, IL
Countries outside the US	CA, DE, ES, GB, IN, IT, MX, PL, TW, ZA
Quantity	26 units
UPC / GTIN / UDI-DI	`00840067100653`
Serial numbers	`19029603AA0224001`, `19029603AA0224002`, `19029603AA0224003`, `19029603AA0224004`, `19029603AA0224005`, `19029603AA0224006`, `19029603AA0224007`, `19029603AA0224008`, `19029603AA0224010`, `19029603AA0224021`, `19029603AA0224027`, `19029603AA0324006`, `19029603AA0324007`, `19029603AA0324008`, `19029603AA0324009`, `19029603AA0324010`, `19029603AA0424001`, `19029603AA0424002`, `19029603AA0424003`, `19029603AA0424006`, `19029603AA0424007`, `19029603AA0424008`, `19029603AA0424009`, `19029603AA0424010`, `19029603AA0524003` and 1 more
Model numbers	`190296-200`

Product

Cascade IOMAX Cortical Module, REF: 190296-200

Reason for recall

Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.

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-2349-2024. 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.