Skintact ECG Electrode FS-50 — Class II medical device recall Z-1350-2015
Terminated recall by Leonhard Lang Medizintechnik GmbH, reported 2015-04-08, distributed in FL. The electrodes may fail to transmit signals.
| Recall number | Z-1350-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leonhard Lang Medizintechnik GmbH, Innsbruck, N/A, Austria |
| Recall initiated | 2015-02-24 |
| Classified | 2015-03-27 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2017-07-26 |
| Distributed | FL |
| Quantity | 364,800 |
| Reason classes | device malfunction |
| Lot numbers | 40115-0322, 40116-0099T, 40116-0152T, 40116-0323, 40117-0091, 40117-0153T, 40117-0325T, 40120-0093, 40120-0154T, 40120-0326T, FS-50, T-60 |
| Model numbers | 50547, 58028 |
Product
Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram.
Reason for recall
The electrodes may fail to transmit signals.
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-1350-2015. 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.