Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode — Class I medical device recall Z-0892-2013
Terminated recall by Ad-Tech Medical Instrument Corporation, reported 2013-03-13, distributed nationwide. The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading the
| Recall number | Z-0892-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ad-Tech Medical Instrument Corporation, Racine, WI, United States |
| Recall initiated | 2012-12-18 |
| Classified | 2013-03-01 |
| Reported by FDA | 2013-03-13 |
| Terminated | 2014-10-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, ES, FR, GB, JP, KR |
| Reason classes | device malfunction |
| Lot numbers | 019020, 08140463, 208140314, 208140343, 208140344, 208140353, 208140354, 208140356R, 208140357R, 208140362, 208140369, 208140374, 208140381, 208140382, 208140387, 208140390, 208140395, 208140398, 208140399, 208140414, 208140417, 208140420, 208140421, 208140422, 208140424, 208140431, 208140432, 208140433, 208140437, 208140439, 20814044, 208140443, 208140445, 208140447, 208140450, 208140452, 208140452R, 208140453, 208140458, 208140463 and 47 more |
| Model numbers | 019020, 08140463, 208140314, 208140343, 208140344, 208140353, 208140354, 208140356R, 208140357R, 208140362, 208140369, 208140374, 208140381, 208140382, 208140387, 208140390, 208140395, 208140398, 208140399, 208140414, 208140417, 208140420, 208140421, 208140422, 208140424 and 124 more |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0892-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.