CLASS II Device recall · Reported 8 Apr 2015 · FDA Enforcement Report
Skintact ECG Electrode FS recalled by Leonhard Lang Medizintechnik
Leonhard Lang Medizintechnik is recalling Skintact ECG Electrode FS-50, distributed in Florida. The recall was initiated on 24 Feb 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1350-2015
- FDA event ID
- 70704
- Recalling firm
- Leonhard Lang Medizintechnik, Innsbruck, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Feb 2015
- FDA classified
- 27 Mar 2015
- Reported
- 8 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 24 Feb 2015 | Recall initiated by company | |
| 27 Mar 2015 | Classified by FDA | +31 days |
| 8 Apr 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The electrodes may fail to transmit signals.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Distributed to FL.
Questions about this recall
Why was it recalled?
The electrodes may fail to transmit signals.
Which lots are affected?
FS-50 Lot: 40120-0093 FS-50 Lot: 40117-0091 FS-50 Lot: 40116-0099 T -60 Lot: 40116-0323 T-60 Lot: 40120-0326 T -60 Lot: 40120-0154 T -60 Lot: 40117-0325 T -60 Lot: 40117-0153 T -60 Lot: 40116-0152 T -60 Lot: 40115-0322
Where was it sold?
Distributed to FL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Leonhard Lang Medizintechnik
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Skintact Electrode for Defibrillation, Pacing, Monitoring recalled | Leonhard Lang Medizintechnik | Other | FL, TX |
| Device | CLASS I | Skintact Electrodes for Defibrillation, DF29N recalled | Leonhard Lang Medizintechnik | Other | FL |
| Device | CLASS II | ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase recalled | Leonhard Lang Medizintechnik | Device Malfunction | FL |
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