ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15… — Class II medical device recall Z-0292-2016
Terminated recall by Leonhard Lang Medizintechnik GmbH, reported 2015-11-25, distributed in FL. There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that the affected el
| Recall number | Z-0292-2016 |
|---|---|
| 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 | 2015-11-02 |
| Classified | 2015-11-18 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2017-11-21 |
| Distributed | FL |
| Countries outside the US | AE, AT, AU, CH, CZ, DE, EE, ES, FI, FR, GB, GR, HR, IE, IT, JP, MT, NO, PL, PT, RO, RS, TH, TR |
Product
ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen 1900000440 59629 Cardionetics CN-15-W60 58789 Lessa 99.832.02 58872 EF Medica FS 50 LG 50359Ultragel FS50LG
Reason for recall
There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that the affected electrodes will transmit a poor signal or no signal at all before reaching the indicated expiration date.
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-0292-2016. 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.