Reported Oct 21, 2026 · Ongoing · Updated Oct 26, 2026
Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653…
Cadwell Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cadwell Industries Inc · 909 N Kellogg St · Kennewick, WA · 99336-7669
Is this the product you have?
- Brand NameIOMAX
- Product NameIOMAX
- Cortical Module Model/Catalog Number190296-200
- UDI-DI code00840067100653
- Product DescriptionThe 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
- ComponentIs the cortical component of the IOMAX system
- Lot codes and dates
- Model/Catalog Number190296-200
- UDI-DI code00840067100653
- Lot CodeThese devices are identified
- by the serial numbers listed below
19029607AA032600719029607AA022601319029607AA042602819029607AA022601019029607AA022600719029607AA032602619029607AA022601519029607AA032602019029607AA032601819029607AA032602119029607AA032602219029607AA022600919029607AA052602219029607AA032601719029607AA032602719029607AA032601619029607AA022601619029607AA032602819029607AA032602419029607AA032602519029607AA032602319029607AA032603119029607AA0326006
- Amount recalled
- 23
Where it was sold
- Nationwide
- TN
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.
This product could cause temporary or reversible health problems — stop using it.
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