Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dual-Sided Interhemispheric Recalled by Ad-Tech Medical Instrument Corporation Due to Supplemental information provided with devices indicates that the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ad-Tech Medical Instrument Corporation directly.
Affected Products
Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural Electrodes
Quantity: 187,666 devices with possible affected supplemetal information
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ad-Tech Medical Instrument Corporation
Ad-Tech Medical Instrument Corporation has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report