Food, drugs, devices › Defibtech, LLC
Device recall: Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), D
FDA enforcement event 96618 is a device recall by Defibtech, LLC of Guilford, CT, initiated 18 Mar 2025 and classified Class II, with 4 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Defibtech, LLC has 6 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Defibtech, LLC, Guilford, CT.
Reason for recall
"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)."
Distribution
"International Only: Switzerland."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1690-2025 | Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language) | 43 units (OUS only) | Class II | Ongoing | 7 May 2025 |
| Z-1691-2025 | Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language) | 13 units (OUS only) | Class II | Ongoing | 7 May 2025 |
| Z-1692-2025 | Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1¿(German/English dual language), DCF-E2310E3/1¿(German/French dual language), DCF-E2310F3/1¿ (French/English dual language), DCF-E2310G3/1¿(French/German dual language), DCF-E2310IT (Italian language) | 212 units (OUS only) | Class II | Ongoing | 7 May 2025 |
| Z-1693-2025 | Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language) | 1 unit (OUS only) | Class II | Ongoing | 7 May 2025 |
Context
Other enforcement events for Defibtech, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 Mar 2025 | Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E22 | Device | Class II | 1 |
| 14 Oct 2024 | Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indic | Device | Class II | 4 |
| 12 Jul 2024 | RMU-2000 Automated Chest Compression Device | Device | Class I | 1 |
| 14 Feb 2023 | DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest | Device | Class II | 1 |
| 27 Apr 2020 | DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A10 | Device | Class II | 3 |
All 6 events for Defibtech, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "International Only: Switzerland."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.