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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94504

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 23, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Cadwell Industries Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Cascade IOMAX Cortical Module, REF: 190296-200

Z-1882-2024
Recall number
Z-1882-2024
Initiated
April 23, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Cadwell Industries Inc
Quantity
54 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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.