Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary Recalled by Ad-Tech Medical Instrument Corporation Due to The microelectrodes are not flush with the silastic...
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
Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.
Quantity: 144 (103 US; 41 OUS)
Why Was This Recalled?
The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the cortical surface, and may have remaining pieces which may fracture and remain in the cortical tissue with the electrode is explanted. Recall expanded on 5/2/2013 to include additional Macro Micro Subdural Electrodes.
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