Disposable Subdermal Needle Electrode — Class II medical device recall Z-1737-2022
Terminated recall by Technomed Europe, reported 2022-09-21, distributed nationwide. Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of
| Recall number | Z-1737-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Technomed Europe, Maastricht-Airport, Netherlands |
| Recall initiated | 2022-08-09 |
| Classified | 2022-09-12 |
| Reported by FDA | 2022-09-21 |
| Terminated | 2024-04-11 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 08718375861530 |
| Lot numbers | 044220, 045077, 045443, 049285 |
| Expiration dates | 2023-01-01, 2023-03-01, 2023-04-01, 2024-07-01 |
Product
Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.
Reason for recall
Burns of varying degrees can occur to patients with electrodes left in while in the MRI scanner as a result of inadequate safety information in the IFU.
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-1737-2022. 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.