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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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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Defibtech Automated External Defibrillators Recalled for Missing Instructions

Agency Publication Date: April 29, 2025
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Summary

Defibtech, LLC is recalling 13 units of their Model DDU-2200 Automated External Defibrillators (AEDs) because they do not include Italian language instructions. The recall affects units distributed in Switzerland, where labeling and instructions must be provided in German, French, and Italian. The affected models include German/English dual-language and French/English dual-language versions. No injuries have been reported.

Risk

Users who speak only Italian may be unable to understand or follow the instructions for the life-saving device during a medical emergency. This could lead to delayed or incorrect treatment.

What You Should Do

  1. This recall affects Defibtech Model DDU-2200 Automated External Defibrillators (Item numbers DCF-E2210-D3/1 and DCF-E2210-F3/1). See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled device immediately.
  3. Contact Defibtech, LLC or your local distributor in Switzerland to arrange for a replacement device or to receive corrected labeling and instructions that include Italian.
  4. Call the FDA at 1-888-463-6332 for more information regarding medical device recalls.

Your Remedy Options

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

Affected Products

Product: Automated External Defibrillators, Model DDU-2200
Variants: German/English dual language, French/English dual language
Model / REF:
DCF-E2210-D3/1
DCF-E2210-F3/1
DDU-2200
Lot Numbers:
400184748
400170814
400180780
400142381
400142390
400142995
400145936
400145955
400149039
400149042
400149094
400145977
400149090
UDI:
00815098020195
10815098020192

Units were distributed outside the United States (Switzerland only).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96653
Status: Active
Manufacturer: Defibtech, LLC
Sold By: Overseas distributors
Manufactured In: United States
Units Affected: 13 units (OUS only)

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 · 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.