Ad-Tech Medical Dual-Sided Subdural Electrodes: MR Safety Issue
Ad-Tech Medical recalls dual-sided subdural electrodes sold through May 2019 due to MR environment safety risks. These devices are approved for use in MRI but not intended for that purpose.
Lower-risk recall
Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.
Contact the company
What happened, in plain English
Ad-Tech Medical is recalling dual-sided subdural electrodes made through May 2019 because they are approved for MRI use but not intended for that purpose. This could lead to safety risks if used in MRI environments. Read more at govinfonow.com/recall/67648-ad-tech-medical-dual-sided-subdural-electrodes-mr-safety-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/67648-ad-tech-medical-dual-sided-subdural-electrodes-mr-safety-issue · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2406-2019
Cite this page
“Ad-Tech Medical Dual-Sided Subdural Electrodes: MR Safety Issue.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/67648-ad-tech-medical-dual-sided-subdural-electrodes-mr-safety-issue. Based on FDA recall #Z-2406-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2406-2019%22&limit=1).
Why it’s dangerous
The electrodes are approved for use in MRI environments but were not designed for that purpose. This mismatch could cause safety issues if the devices are used in MRI settings where they are not intended to be.
Who’s affected
Medical professionals using these electrodes in MRI settings may be affected. Patients receiving these electrodes during surgery could be at risk if exposed to MRI environments.
How to tell if you have this one
Look for dual-sided subdural electrodes with catalog numbers or lot numbers distributed through May 30, 2019. The product name includes 'Wyler Subdural Electrodes' and 'Dual-Sided Interhemispheric, Grid, Intraoperative, Strip'.
- Brand
Ad-Tech Medical- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Worldwide distribution to Albania, Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, Netherlands, Nicaragua, Pakistan, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Syria, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2406-2019 | Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes; All catalog numbers and lot numbers distributed through May 30, 2019 | 187,666 devices with possible affected supplemetal information |
| Z-2407-2019 | Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes; All catalog numbers and lot numbers distributed through May 30, 2019 | 107,757 devices with possible affected supplemetal information |
| Z-2408-2019 | Skull Anchor Bolts; All catalog numbers and lot numbers distributed through May 30, 2019 | 22,810 devices with possible affected supplemetal information |
What to do — step by step
Check Product Details
Identify if your electrodes have catalog numbers or lot numbers distributed through May 30, 2019.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
FDA distribution: “Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 3.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of injury from using these electrodes?
The recall indicates a potential safety risk if used in MRI environments, but no specific injury mechanism is described.
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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-2406-2019 (June 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2406-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.