Recall Z-0141-2027— Cadwell Industries Inc

Name: FDA recall Z-0141-2027
Creator: U.S. Food and Drug Administration
Published: 2026-08-18

Class II · Ongoing

Class II FDA medical device recall by Cadwell Industries Inc, initiated 2026-08-18. It names one FDA 510(k) clearance: K162199. 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. 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..

Recalling firm: Cadwell Industries Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-08-18
Firm location: Kennewick, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K162199 — Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.·cleared 2017-03-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.