Food, drugs, devices › Defibtech, LLC
Device recall: DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A10
FDA enforcement event 85702 is a device recall by Defibtech, LLC of Guilford, CT, initiated 27 Apr 2020 and classified Class II, with 3 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. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 8 Jan 2021. 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
"A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range."
Distribution
"Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2392-2020 | DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DCF-C2310EN DCF-E2310CA DCF-E2310EN UDI 00815098020201, 00815098020225, 00815098020232 Product Usage: Automated External… | 860 | Class II | Terminated | 24 Jun 2020 |
| Z-2393-2020 | DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally. | 860 | Class II | Terminated | 24 Jun 2020 |
| Z-2394-2020 | DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN DCF-A2463EN DCF-E2460DE DCF-E2460EN DCF-E2460FR DCF-E2460TH UDI 00815098020287, 00815098020317 Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA)… | 860 | Class II | Terminated | 24 Jun 2020 |
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 |
| 18 Mar 2025 | Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), D | Device | Class II | 4 |
| 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 |
All 6 events for Defibtech, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range."
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: "Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 Jan 2021. "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.