Recall archive / FDA device enforcement
Cascade IOMAX Cortical Module, REF: 190296-200 — FDA record Z-2349-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 17, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Cascade IOMAX Cortical Module, REF: 190296-200
- Reason
- Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
- Classification
- Class II
- Recalling firm
- Cadwell Industries Inc
- Quantity
- 26 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2349-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: 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, 19029603AA0524004 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 24, 2024
- Recall initiation date
- May 17, 2024
- Center classification date
- Jul 12, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.