Cadwell IOMAX Cortical Module
The IOMAX Cortical Module may unintentionally deliver electrical stimulation or allow unintended current to reach the patient.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Cadwell Industries Inc is recalling the IOMAX Cortical Module because a defective printed circuit board assembly may cause the device to unintentionally deliver electrical stimulation to the patient or allow an unintended electrical current to reach the patient. The recall began on August 18, 2026, and was added to the FDA's Enforcement Report on October 9, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
IOMAX Cortical Module
- Model
- 190296-200
From the FDA notice
UDI-DI code: 00840067100653
Details
- Company began the recall
- Event ID
- 99774
- Company
- Cadwell Industries Inc
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
