Defibtech, LLC 2025-05-07 Health serious FDA
Health · FDA · Recall #FDA-Z-1690-2025
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers:… Recall
Issued May 7, 2025 · Defibtech, LLC
In May 2025, Defibtech, LLC recalled the Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers:…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
What you should do
- 1 Stop using Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers:… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Defibtech, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Defibtech, LLC
- Category
- Health
- Recall date
- May 7, 2025
- Units affected
- Not reported
- Sold at
- International Only: Switzerland.
- Recall number
- FDA-Z-1690-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Defibtech, LLC has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.