Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 4, 2024
Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.)
Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed a…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Defibtech, LLC recalled Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and… - a moderate-severity action.
Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and… was recalled by Defibtech, LLC in December 4, 2024. Reason: Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labe…. Check the official notice for the remedy. Verify recall #Z-0503-2025 with the FDA Devices before acting.
The recall
Defibtech, LLC issued this moderate-severity FDA Devices recall-Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labe….
- Moderate
- severity level
- Class II
- classification
- December 4, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0503-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0503-2025) was formally reported on December 4, 2024, with the manufacturer initiating the action on October 14, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Defibtech, LLC is listed as the recalling firm, operating out of Guilford, CT. Federal records list the affected scope as 22,294 total.
The documented reason for this recall is: Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, coul… Distribution data in the federal record shows the product reached: Ireland. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
22,294 total
Related Recalls
6
3 from same agency
Product description
Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.)
Reason for recall
Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0503-2025 |
| Date reported | December 4, 2024 |
| Date initiated | October 14, 2024 |
| Recalling firm | Defibtech, LLC |
| Firm location | Guilford, CT |
| Affected scope | 22,294 total |
| Distribution | Ireland |
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-0503-2025) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.). Recalled by Defibtech, LLC. Units affected: 22,294 total.
Why was this product recalled? ▼
Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2024. Severity: Moderate. Recall number: Z-0503-2025.
Where was the recalled product distributed? ▼
Distribution: Ireland.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0503-2025) 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 4, 2024. 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.