Stop using now Medical device recall · FDA · Published August 18, 2026

IOMAX Cortical Module Recall: Risk of Unintended Electrical Stimulation

Cadwell Industries recalls 23 IOMAX Cortical Modules with defective printed circuit boards that may deliver unintended electrical stimulation. Affected units have specific serial numbers and were sold worldwide. Stop using immediately.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0141-2027Medical device IOMAX ›

Stop using this now

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.

✎ GovInfoNow plain-language explainer

Cadwell Industries recalls 23 IOMAX Cortical Modules due to a defective printed circuit board that could cause unintended electrical stimulation. This poses a risk of injury to patients using the device. Read more at govinfonow.com/recall/1764880-cadwell-industries-inc-recalls-brand-name-iomax-product-name-iomax.

Source Summary by GovInfoNow · govinfonow.com/recall/1764880-cadwell-industries-inc-recalls-brand-name-iomax-product-name-iomax · Published October 27, 2026 · Updated October 27, 2026 · FDA enforcement record: FDA #Z-0141-2027

Cite this page

“IOMAX Cortical Module Recall: Risk of Unintended Electrical Stimulation.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764880-cadwell-industries-inc-recalls-brand-name-iomax-product-name-iomax. Based on FDA recall #Z-0141-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0141-2027%22&limit=1).

Cadwell Industries Inc recalled the IOMAX Cortical Module due to a defective printed circuit board that may cause unintended electrical stimulation. The FDA announced this Class II recall on August 18, 2026.

How to tell if you have it

Brand: IOMAX
Product Name: IOMAX Cortical Module
Model/Catalog Number: 190296-200
UDI-DI code: 00840067100653
Lot Code/Serial Numbers: 19029607AA0326007, 19029607AA0226013, 19029607AA0426028, 19029607AA0226010, 19029607AA0226007, 19029607AA0326026, 19029607AA0226015, 19029607AA0326020, 19029607AA0326018, 19029607AA0326021, 19029607AA0326022, 19029607AA0226009, 19029607AA0526022, 19029607AA0326017, 19029607AA0326027, 19029607AA0326016, 19029607AA0226016, 19029607AA0326028, 19029607AA0326024, 19029607AA0326025, 19029607AA0326023, 19029607AA0326031, 19029607AA0326006

The hazard

The stimulator device contains a defective printed circuit board assembly that may cause the device to unintentionally deliver electrical stimulation to the patient or allow an unintended electrical current to reach the patient.

Context

GovInfoNow's records show Cadwell Industries Inc has two other recalls on record since April 23, 2024. On May 17, 2024, Cadwell issued a recall for the Cascade IOMAX Cortical Module due to a defective circuit board risk of unintended electrical stimulation. Other recent recalls of similar products include the Getinge SERVO-U/N Ventilator Sensor Module Recall (June 30, 2026) and the Tobii Dynavox TD Navio Maxi Speech Device Recall (July 8, 2026).

How to tell if you have this one

Check for the serial numbers: 19029607AA0326007, 19029607AA0226013, 19029607AA0426028, and other listed serial numbers. The device is sold worldwide and distributed in specific countries including the United States.

Brand
IOMAX
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop using it now
Immediately stop using the IOMAX Cortical Module if it has the listed serial numbers.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Aug 18, 2026Firm started the recall
Oct 9, 2026FDA classified it Class II
Oct 21, 2026Published in FDA’s Enforcement Report
Oct 27, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What are the serial numbers for the recalled units?

The recalled units have serial numbers: 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 the device sold?

The IOMAX Cortical Module was sold worldwide, including the United States, Spain, Vietnam, Malaysia, Saudi Arabia, Thailand, Israel, Mexico, Turkey, Oman, Colombia, Brazil, Belgium, Italy, South Africa, and Switzerland.

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Link to this recall

<a href="https://govinfonow.com/recall/1764880-cadwell-industries-inc-recalls-brand-name-iomax-product-name-iomax">IOMAX Cortical Module Recall: Risk of Unintended Electrical Stimulation (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0141-2027 (August 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0141-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.