Skintact Electrode for Defibrillation — Class I medical device recall Z-3109-2017
Terminated recall by Leonhard Lang Medizintechnik GmbH, reported 2017-09-20, distributed in FL, TX. Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not con
| Recall number | Z-3109-2017 |
|---|---|
| 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 | 2017-08-08 |
| Classified | 2017-09-12 |
| Reported by FDA | 2017-09-20 |
| Terminated | 2020-06-09 |
| Distributed | FL, TX |
| Countries outside the US | AE, AT, CN, DE, ES, FR, GB, GR, HU, IN, IT, KR, PA, PH, PL, RS, SA, ZA |
| Quantity | 8,249 units |
| Lot numbers | 40806-0972, 41029-0770, 41203-0973, 41219-0778, 50116-0975, 50211-0974, 50402-0974, 50403-0772, 50527-0974 |
| Model numbers | DF59N |
| Expiration dates | 2017-09 |
Product
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external defibrillators
Reason for recall
Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. 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-3109-2017. 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.