Class 2 Device Recall IOMAX

• Date Initiated by Firm: August 18, 2026
• Date Posted: October 09, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0141-2027
• Recall Event ID: 99774
• 510(K)Number: K162199
• Product Classification: Stimulator, electrical, evoked response - Product Code GWF
• Product: 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: 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
• FEI Number: 3020018
• Recalling Firm/ Manufacturer: Cadwell Industries Inc; 909 N Kellogg St; Kennewick WA 99336-7669
• For Additional Information Contact: 509-735-6481
• Manufacturer Reason for Recall: 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 Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 23
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GWF