Disposable Subdermal Needle Electrode — Class II medical device recall Z-0465-2022
Terminated recall by Technomed Europe, reported 2022-01-19, distributed nationwide. There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining i
| Recall number | Z-0465-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Technomed Europe, Maastricht-Airport, N/A, Netherlands |
| Recall initiated | 2021-12-08 |
| Classified | 2022-01-07 |
| Reported by FDA | 2022-01-19 |
| Terminated | 2024-05-31 |
| Distributed | Nationwide (US) |
| Quantity | 117,672 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 08718375861547, 08718375861684, 08718375861691, 08718375861707, 08718375865439, 08718375866863, 08718375867549, 08718375867853 |
| Model numbers | TE/S50715-001, TE/S50715-001-C, TE/S50725-001C |
Product
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Reason for recall
There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
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-0465-2022. 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.