CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report

Iomax Cortical Module recalled by Cadwell Industries

Cadwell Industries is recalling Iomax Cortical Module, distributed nationwide in the US. The recall was initiated on 18 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/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

Quantity recalled23

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0141-2027
FDA event ID: 99774
Recalling firm: Cadwell Industries, Kennewick, WA
Classification: Class II
Status: Ongoing
Recall initiated: 18 Aug 2026
FDA classified: 9 Oct 2026
Reported: 21 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

18 Aug 2026	Recall initiated by company
9 Oct 2026	Classified by FDA	+52 days
21 Oct 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Tennessee

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Cadwell Industries

All 3

Reported	Class	Recall	Company	Reason	Where
24 Jul 2024Device	CLASS II	Cascade Iomax Cortical Module recalled by Cadwell Industries	Cadwell Industries	Device Malfunction	CA, IL
29 May 2024Device	CLASS II	Cascade Iomax Cortical Module recalled by Cadwell Industries	Cadwell Industries	Other	Nationwide

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