Cascade IOMAX Cortical Module (Cadwell) – Insulator Risk (2024)
Incorrect device installation may result in electrical arcing that can cause unintended patient shock.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cascade IOMAX Cortical Module, REF: 190296-200
Brand
Cadwell Industries Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI: 00840067100653/ Serial numbers: 19029603AA1223002 19029603AA1223003 19029603AA1223004 19029603AA1223005 19029603AA1223006 19029603AA1223007 19029603AA1223011 19029603AA1223012 19029603AA1223013 19029603AA1223014 19029603AA1223015 19029603AA1223016 19029603AA1223017 19029603AA1223018 19029603AA1223019 19029603AA1223020 19029603AA1223024 19029603AB1223021 19029603AB1223023 19029603AA1223025 19029603AA0124001 19029603AA0124002 19029603AA0224008 19029603AA0124007 19029603AA0124012 19029603AA0124017 19029603AA0124004 19029603AA0124010 19029603AA0124016 19029603AA0224010 19029603AA0124015 19029603AA1223026 19029603AA0124008 19029603AA0124009 19029603AA1223027 19029603AA1223028 19029603AA1223029 19029603AA0124003 19029603AA0224001 19029603AA1223030 19029603AA1223008 19029603AA1223009 19029603AA0124013 19029603AA1223031 19029603AA1223001 19029603AA0224002 19029603AA0224003 19029603AA0224004 19029603AA0224005 19029603AA0224006 19029603AA0224007 19029603AA0124014 19029603AA0224009 19029603AA0124011
Cadwell Industries Inc is recalling Cascade IOMAX Cortical Module, REF: 190296-200 due to There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient co. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 4/22/24, Cadwell Industries, Inc. issued a "Urgent: Medical Device Recall" notification to affected consignees via Email: 1. Cease use of the device immediately and return all identified devices to Cadwell Industries, Inc. 2. Please complete the attached response form and return via email to quality@cadwell.com. 3. Please circulate this notice to all those who require awareness within your organization or to any organization whom you may have transferred the IOMAX Cortical Module to. 4. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026