Skintact Electrodes for Defibrillation — Class I medical device recall Z-0004-2017
Terminated recall by Leonhard Lang Medizintechnik GmbH, reported 2016-10-26, distributed in FL. There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch Ally
| Recall number | Z-0004-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leonhard Lang Medizintechnik GmbH, Innsbruck, N/A, Austria |
| Recall initiated | 2016-09-01 |
| Classified | 2016-10-14 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2019-03-26 |
| Distributed | FL |
| Countries outside the US | AE, DE, FR, GB, IL, IT, LB, PL, RS, SI, TH, ZA |
Product
Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
Reason for recall
There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch Allyn AED 10 only with delay or not at all. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.
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-0004-2017. 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.