Class II — Cadwell Industries Inc
| Recalling firm | CADWELL INDUSTRIES, INC. |
|---|---|
| Registered facility | CADWELL INDUSTRIES, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Cascade IOMAX Cortical Module, REF: 190296-200 |
| Quantity | 54 units |
| Distribution | Worldwide - US Nationwide distribution in the state of MD and the countries of Mexico, Canada, Malaysia, India, Taiwan, Saudi Arabia, European Union, Switzerland, South Africa, Iraq, United Kingdom. |
| Initiated | 2024-04-23 |
| Classified | 2024-05-22 |
| Recall number | Z-1882-2024 |
| Initiation | Voluntary: 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-1882-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94504/
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