Recall Atlas
Drugs & medicalClass II

Cadwell Industries Inc recalls Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description:…

Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to…

Read the official notice →
Date
2026-10-21
Country
United States
Brand
Cadwell Industries
Product
Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description:…
Classification
Class II
Units
Worldwide - US Nationwide distribution in the state of TN and the countries of…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Cadwell Industries recalls

  1. 2024-07-24
  2. Drugs & medicalClass II

    Cadwell Industries Inc recalls Cascade IOMAX Cortical Module, REF: 190296-200

    Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.

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  3. 2024-05-29
  4. Drugs & medicalClass II

    Cadwell Industries Inc recalls Cascade IOMAX Cortical Module, REF: 190296-200

    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.

    FDA · DeviceCadwell Industries IncWorldwide - US Nationwide distribution in the state of MD and the countries of…Official notice →
All 3 Cadwell Industries recalls →

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