Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported October 26, 2016
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.
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 i…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Leonhard Lang Medizintechnik GmbH recalled Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode… - a critical-severity action.
Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode… was recalled by Leonhard Lang Medizintechnik GmbH in October 26, 2016. Reason: There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch All…. Check the official notice for the remedy. Verify recall #Z-0004-2017 with the FDA Devices before acting.
The recall
Leonhard Lang Medizintechnik GmbH issued this critical-severity FDA Devices recall-There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch All….
- Critical
- severity level
- Class I
- classification
- October 26, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0004-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0004-2017) was formally reported on October 26, 2016, with the manufacturer initiating the action on September 1, 2016. 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 11,110 ( US 8,040; OUS 3,070).
The documented reason for this recall is: 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 thre… Distribution data in the federal record shows the product reached: Worldwide Distribution - US, to the state of Florida; and, the countries of South Africa, Germany, Slovenia, France, United Arab Emirates, Great Britain, Italy, Israel, Serbia, Thailand, Thailand, South Africa, Lebanon,…. 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
11,110 ( US 8,040; OUS 3,070)
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0004-2017 |
| Date reported | October 26, 2016 |
| Date initiated | September 1, 2016 |
| Recalling firm | Leonhard Lang Medizintechnik GmbH |
| Firm location | Innsbruck, N/A |
| Affected scope | 11,110 ( US 8,040; OUS 3,070) |
| Distribution | Worldwide Distribution - US, to the state of Florida; and, the countries of South Africa, Germany, Slovenia, France, United Arab Emirates, Great Britain, Italy, Israel, Serbia, Thailand, Thailand, South Africa, Lebanon, and Poland. |
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-0004-2017) 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 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.. Recalled by Leonhard Lang Medizintechnik GmbH. Units affected: 11,110 ( US 8,040; OUS 3,070).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 26, 2016. Severity: Critical. Recall number: Z-0004-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US, to the state of Florida; and, the countries of South Africa, Germany, Slovenia, France, United Arab Emirates, Great Britain, Italy, Israel, Serbia, Thailand, Thailand, South Africa, Lebanon, and Poland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0004-2017) 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 October 26, 2016. 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.