Kennewick, WA, United States
Cadwell Industries Inc recalls
3 recalls recorded since 2018, most recently on 18 August 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 August 2026
- Reason
- 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 reach the patient.
- Distribution
- Worldwide - US Nationwide distribution in the state of TN and the countries of Spain, Vietnam, Malaysia, Saudi Arabia, Thailand, Israel, Mexico, Turkey, Oman, Colombia, Brazil, Belgium, Italy, South Africa, and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0141-2027
- Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low current electri
Ongoing Class II Medical devices
- Recall started
- 17 May 2024
- Reason
- Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
- Distribution
- US: IL CA OUS: Canada, Germany, India, Italy, Mexico, Poland, South Africa, Spain, Taiwan, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2349-2024
- Cascade IOMAX Cortical Module, REF: 190296-200
Ongoing Class II Medical devices
- Recall started
- 23 April 2024
- Reason
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1882-2024
- Cascade IOMAX Cortical Module, REF: 190296-200
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.