Z-0502-2025Class II

Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX...

Name: Z-0502-2025 Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX...
Creator: Defibtech, LLC
Published: 2024-10-14
License: https://open.fda.gov/license/

Defibtech LLC / initiated 2024-10-14 / Open, Classified / root cause: labeling and UDI

FDA source

Defibtech, LLC began a recall of Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden... on 2024-10-14. FDA classified it as Class II and gives the reason as "Within the Irish Market, 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 lead...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0502-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-14
Posted: 2024-11-25
Recalling firm: Defibtech LLC
Product: Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Within the Irish Market, 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 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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Defibtech issued Urgent Field Safety Notice on 10/14/24 by e-mail to the Irish Market h via the Distributor Oxygen Care Ltd. titled: Unauthorized Label Applied to Defibtech, LLC's Automated External Defibrillator (AED} Pads within the Irish Market. Letter states reason for recall, health risk and action to take: Actions to be taken by the Customer/User: 1. Check the label of your Defibtech AED Pads. Please review Attachment B which clearly shows authorised labelled Defibtech AED Pads versus unauthorised labelled Defibtech AED Pads. 2. Please confirm receipt of this notice by completing Attachment C "Customer Reply Form", attached to this notice, and return to Oxygen Care, Ltd (our new official Irish Distributor) so that our records may be updated. 3. If an unauthorised label applied to Defibtech AED Pads is confirmed, please urgently return the Defibtech AED Pads along with the completed "Customer Reply Form" to Oxygen Care. Upon receipt of the unauthorized labelled Defibtech AED Pads, Oxygen Care will send a replacement set of authorised labelled Defibtech AED Pads to you at no charge: Oxygen Care Ltd.: Email: Sales@ oxyge n-care.ie Phone: 01 2769700 Address: 2 Holfeld Business Park, Kilmacanogue. Co. Wicklow. Eircode A98 NP27 4. If you have transferred the Defibtech AED Pads to another entity or department, please contact Oxygen Care as per the above contact details. The unauthorised labelled Defibtech AED pads were re-labelled with expiration dates beyond the shelf life of the Defibtech AED Pads. The affected Defibtech AED Pads should not be used. Defibtech will continue to work closely with regulatory authorities toward the resolution of this issue. Defibtech is committed to patient safety and is focused on providing the highest level of customer satisfaction. We appreciate your cooperation and sincerely apologize for any inconvenience this may cause you.
Quantity in commerce: 22,294 total
Distribution: Ireland
Product codes and lots: UDI-DI: 00815098020423, DDP-100 adult defibrillation pads, single configuration; 30815098020424, DDP-100 adult defibrillation pads, 10 pairs; 50815098020428, DDP-100 adult defibrillation pads, 40 pairs;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0502-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0502-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-21
Z-0503-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-21
Z-0504-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-21
Z-0505-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-21

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)