Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported September 20, 2017
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
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 si…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Leonhard Lang Medizintechnik GmbH recalled Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usag… - a critical-severity action.
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usag… was recalled by Leonhard Lang Medizintechnik GmbH in September 20, 2017. Reason: Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not co…. Check the official notice for the remedy. Verify recall #Z-3109-2017 with the FDA Devices before acting.
The recall
Leonhard Lang Medizintechnik GmbH issued this critical-severity FDA Devices recall-Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not co….
- Critical
- severity level
- 8K units
- affected scope
- Class I
- classification
- September 20, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3109-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3109-2017) was formally reported on September 20, 2017, with the manufacturer initiating the action on August 8, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. Leonhard Lang Medizintechnik GmbH is listed as the recalling firm, operating out of Innsbruck, N/A. Federal records list the affected scope as 8,249 units total.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Worldwide distribution. US distribution in the states of : FL & TX. Austria, China, France, Germany, Greece, Hungary, India, Italy, Panama, Philippines, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8,249 units total
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-3109-2017 |
| Date reported | September 20, 2017 |
| Date initiated | August 8, 2017 |
| Recalling firm | Leonhard Lang Medizintechnik GmbH |
| Firm location | Innsbruck, N/A |
| Affected scope | 8,249 units total |
| Distribution | Worldwide distribution. US distribution in the states of : FL & TX. Austria, China, France, Germany, Greece, Hungary, India, Italy, Panama, Philippines, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, United Arab Emirates… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-3109-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Leonhard Lang Medizintechnik GmbH. Units affected: 8,249 units total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 20, 2017. Severity: Critical. Recall number: Z-3109-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US distribution in the states of : FL & TX. Austria, China, France, Germany, Greece, Hungary, India, Italy, Panama, Philippines, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3109-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 20, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.