Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported December 31, 2014
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only.
The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Leonhard Lang Gmbh recalled GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 20… - a critical-severity action.
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 20… was recalled by Leonhard Lang Gmbh in December 31, 2014. Reason: The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a res…. Check the official notice for the remedy. Verify recall #Z-0802-2015 with the FDA Devices before acting.
The recall
Leonhard Lang Gmbh issued this critical-severity FDA Devices recall-The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a res….
- Critical
- severity level
- Class I
- classification
- December 31, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0802-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0802-2015) was formally reported on December 31, 2014, with the manufacturer initiating the action on December 3, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Leonhard Lang Gmbh is listed as the recalling firm, operating out of Innsbruck. Federal records list the affected scope as 1080 pieces.
The documented reason for this recall is: The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a life threatening si… Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of OH and TX.. 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
1080 pieces
Related Recalls
6
3 from same agency
Product description
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only.
Reason for recall
The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0802-2015 |
| Date reported | December 31, 2014 |
| Date initiated | December 3, 2014 |
| Recalling firm | Leonhard Lang Gmbh |
| Firm location | Innsbruck |
| Affected scope | 1080 pieces |
| Distribution | US Nationwide Distribution in the states of OH and TX. |
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-0802-2015) 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? ▼
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external defibrillation, pacing, monitoring and cardioversion. The device is non-sterile and for single use only.. Recalled by Leonhard Lang Gmbh. Units affected: 1080 pieces.
Why was this product recalled? ▼
The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 31, 2014. Severity: Critical. Recall number: Z-0802-2015.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of OH and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0802-2015) 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 December 31, 2014. 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.