Data Foundry

Medical device recalls 2024

Cascade IOMAX Cortical Module — Class II medical device recall Z-1882-2024

Ongoing recall by Cadwell Industries Inc, reported 2024-05-29, distributed nationwide. There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly wh

Recall numberZ-1882-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCadwell Industries Inc, Kennewick, WA, United States
Recall initiated2024-04-23
Classified2024-05-22
Reported by FDA2024-05-29
DistributedNationwide (US)
Countries outside the USCA, CH, GB, IN, IQ, MX, MY, SA, TW, ZA
Quantity54 units
UPC / GTIN / UDI-DI00840067100653
Serial numbers19029603AA0124001, 19029603AA0124002, 19029603AA0124003, 19029603AA0124004, 19029603AA0124007, 19029603AA0124008, 19029603AA0124009, 19029603AA0124010, 19029603AA0124011, 19029603AA0124012, 19029603AA0124013, 19029603AA0124014, 19029603AA0124015, 19029603AA0124016, 19029603AA0124017, 19029603AA0224001, 19029603AA0224002, 19029603AA0224003, 19029603AA0224004, 19029603AA0224005, 19029603AA0224006, 19029603AA0224007, 19029603AA0224008, 19029603AA0224009, 19029603AA0224010 and 29 more
Model numbers190296-200

Product

Cascade IOMAX Cortical Module, REF: 190296-200

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1882-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.