Brand Name: IOMAX recallZ-0141-2027 · Cadwell Industries Inc · initiated Aug 18, 2026
Open, Classified All recalls posted in October 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cadwell Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
On 08/18/2026, an "URGENT: MEDICAL DEVICE RECALL" Letter was emailed informing customers that, a manufacturing defect was identified in a limited number of IOMAX Cortical Modules. Following a recent change in printed circuit board assembly (PCBA) vendor, the defect was discovered during routine production processes on a limited number of PCBA s that were used in IOMAX Cortical Modules. The identified risk is specific to the Cortical Module and Cascade Surgical Studio (CSS). However, because Cortical Modules can be used with Zenith, Arc, and CSS, a module currently in use with Zenith or Arc could later be connected to CSS. Cadwell is therefore recalling all potentially affected Cortical Modules regardless of current host system. If the defective PCBA is present, it could potential cause unintentionally deliver electrical stimulation to the patient, or allow a small amount of unintended electrical current to reach the patient. Customers are instructed to return all identified devices to Cadwell Industries, Inc. Cadwell Industries, Inc. is voluntarily recalling and replacing or repairing all affected devices from the field.
Recall details
- Recall number
- Z-0141-2027
- Recall class
- Not yet classified by the FDA
- Status
- Open, Classified
- Initiated by the company
- Aug 18, 2026
- Posted by the FDA
- Oct 9, 2026
- Recalling firm
- Cadwell Industries Inc
- Quantity
- 23
- Product code
- GWF
- FDA submissions
- K162199
- 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.
Product description
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 electrical stimulator, a TCS stimulator, a visual stimulator and an auditory stimulator. The low current stimulator has one (1) constant current output pair with a current range of 0.01-20 mA. The TCS stimulator has nine (9) independent constant current/constant voltage outputs, with current range of 50-1500 mA and voltage range of 50-1000 V. Component: Is the cortical component of the IOMAX system
Code information (models, lots, serial numbers)
Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Lot Code: These devices are identified by the serial numbers listed below: 19029607AA0326007 19029607AA0226013 19029607AA0426028 19029607AA0226010 19029607AA0226007 19029607AA0326026 19029607AA0226015 19029607AA0326020 19029607AA0326018 19029607AA0326021 19029607AA0326022 19029607AA0226009 19029607AA0526022 19029607AA0326017 19029607AA0326027 19029607AA0326016 19029607AA0226016 19029607AA0326028 19029607AA0326024 19029607AA0326025 19029607AA0326023 19029607AA0326031 19029607AA0326006
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cascade IOMAX Intraoperative Monitor 190296-200Cadwell Industries, Inc. · DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT3 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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