Depth Electrodes — Class II medical device recall Z-2407-2019
Terminated recall by Ad-Tech Medical Instrument Corporation, reported 2019-09-04, distributed nationwide. Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and a
| Recall number | Z-2407-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ad-Tech Medical Instrument Corporation, Oak Creek, WI, United States |
| Recall initiated | 2019-06-18 |
| Classified | 2019-08-27 |
| Reported by FDA | 2019-09-04 |
| Terminated | 2023-01-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BR, CA, CL, CN, CO, CY, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, GT, HK, HR, IE, IL, IN, IT, JO, JP, KR, KW, LK, MX, MY, NI, NL, PA, PK, PL, PT, QA, RO, RU, SA, SE, SG, SI, TH, TR, TW, UY, VE, VN, ZA |
| Quantity | 107,757 devices |
| Reason classes | unapproved product |
Product
Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes
Reason for 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.
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-2407-2019. 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.