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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Diagnostic Equipment

Defibtech Defibrillation Pads Recalled Due to Labeling and Expiration Risks

Agency Publication Date: November 25, 2024
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Summary

Defibtech, LLC is recalling 22,294 adult and pediatric defibrillation pads used with Lifeline and Lifeline View AED models. The recall was issued because a select number of pads in the Irish market had authorized labels removed and replaced with unauthorized labels, which could make expired pads appear as though they are still safe to use. Expired pads may have dried hydrogel, which can prevent the AED from establishing a proper electrical connection with a patient during a sudden cardiac arrest. No injuries have been reported to date.

Risk

If the pads are expired and the hydrogel has dried, the AED may deliver less energy than required or fail to deliver a shock entirely, which can lead to a failure to resuscitate a patient in a life-threatening emergency.

What You Should Do

  1. This recall affects Defibtech DDP-100 and DDP-2001 Adult Defibrillation Pads, as well as DDP-200P and DDP-2002 Pediatric Defibrillation Pads, used with various Lifeline series AED models.
  2. Check the labeling on your defibrillation pads for any signs of tampering or unauthorized labels, and verify the expiration dates. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Defibtech, LLC or your authorized distributor to arrange for a return, replacement, or correction of the pads.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated exchange or correction

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Defibtech DDP-100 Adult Defibrillation Pads
Variants: Single configuration, 10 pairs, 40 pairs
Model / REF:
DDP-100
DDU-1:XX Series
UDI:
00815098020423
30815098020424
50815098020428

Indicated for use with Lifeline and Lifeline Auto AED models.

Product: Defibtech DDP-200P Pediatric Defibrillation Pads
Variants: Single pair, Single pair configuration, 20 pairs
Model / REF:
DDP-200P
DDU-l XX Series
UDI:
00815098020430
10815098020437
40815098020438

Indicated for use with Lifeline and Lifeline Auto AED models.

Product: Defibtech DDP-2001 Adult Defibrillation Pads
Variants: Single pack, 10 pairs, 40 pairs
Model / REF:
DDP-2001
DDU-2XXX Series
UDI:
00815098020447
30815098020448
50815098020442

Indicated for use with Lifeline View Auto, Lifeline Pro, Lifeline ECG, and Lifeline View AED models.

Product: Defibtech DDP-2002 Pediatric Defibrillation Pads
Variants: Single pair, Single pair configuration, 20 pairs
Model / REF:
DDP-2002
DDU-2XXX Series
UDI:
00815098020454
10815098020451
40815098020452

Indicated for use with Lifeline View Auto, Lifeline Pro, Lifeline ECG, and Lifeline View AED models.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95594
Status: Active
Manufacturer: Defibtech, LLC
Sold By: Authorized distributors
Manufactured In: United States
Units Affected: 4 products (22,294 total)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.