CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report
DDP-200P: Pediatric Defibrillation Pads 0 For use with AED recalled
Defibtech is recalling DDP-200P: Pediatric Defibrillation Pads 0 For use with AED. The recall was initiated on 14 Oct 2024 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-0503-2025
- FDA event ID
- 95594
- Recalling firm
- Defibtech, Guilford, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Oct 2024
- FDA classified
- 21 Nov 2024
- Reported
- 4 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Oct 2024 | Recall initiated by company | |
| 21 Nov 2024 | Classified by FDA | +38 days |
| 4 Dec 2024 | Published in enforcement report | +13 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.)
Where it was distributed
Ireland
Questions about this recall
Why was it 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 lots are affected?
UDI-DI: 00815098020430, DDP-200P pediatric defibrillation pads, single pair; 10815098020437, DDP-200P pediatric defibrillation pads, single pair configuration; 40815098020438, DDP-200P pediatric defibrillation pads, 20 pairs
Where was it sold?
Ireland
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.
Other products in this recall event
3 other products · FDA event 95594This product is part of a recall event; the main page for the event is DDP-2001: Adult Defibrillation Pads For use with AED recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DDP-2001: Adult Defibrillation Pads For use with AED recalled | Defibtech | Other | CT | |
| CLASS II | DDP-100 Adult Defibrillation Pads For use with AED recalled by Defibtech | Defibtech | Other | CT | |
| CLASS II | DDP-2002: Pediatric Defibrillation Pads For use with AED recalled | Defibtech | Other | CT |
More recalls from Defibtech
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT |
| Device | CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT |
| Device | CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT |
| Device | CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT |
| Device | CLASS II | Semi-Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT |
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