The Recall Desk
HighFDA (Devices)·Z-1694-2025·Announced 2025-05-07

[pending] Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dua

Pending LLM rewrite. Source: FDA_DEVICE Z-1694-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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).

The recalled product

Product
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
Manufacturer
Defibtech, LLC
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

  • UDI-DIs
  • 00815098020195 (DDU-2200
  • export version)
  • 10815098020192 (DDU-2200
  • export version (configuration level))
  • Lot numbers: 400184748
  • 400170814
  • 400180780
  • 400142381
  • 400142390
  • 400142995
  • 400145936
  • 400145955
  • 400149039
  • 400149042
  • 400149094
  • 400145977
  • 400149090

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category