Z-1882-2024Class II

Cascade IOMAX Cortical Module, REF: 190296-200

Name: Z-1882-2024 Cascade IOMAX Cortical Module, REF: 190296-200
Creator: Cadwell Industries Inc
Published: 2024-04-23
License: https://open.fda.gov/license/

Cadwell Industries Inc / initiated 2024-04-23 / Open, Classified / root cause: manufacturing process

FDA source

Cadwell Industries Inc began a recall of Cascade IOMAX Cortical Module, REF: 190296-200 on 2024-04-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1882-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-23
Posted: 2024-05-22
Recalling firm: Cadwell Industries Inc
Product: Cascade IOMAX Cortical Module, REF: 190296-200
Product code: GWF Stimulator, Electrical, Evoked Response
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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 [email protected]. 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.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1882-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1882-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-22

Product code GWF

K162199Class IICascade IOMAX Intraoperative MonitorCadwell Industries, Inc. / cleared 2017-03-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)