CLASS II Device recall · Reported 24 Jun 2020 · FDA Enforcement Report
DDU-2400EN Lifeline PRO recalled by Defibtech
Defibtech is recalling DDU-2400EN Lifeline PRO, distributed nationwide in the US. The recall was initiated on 27 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2393-2020
- FDA event ID
- 85702
- Recalling firm
- Defibtech, Guilford, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Apr 2020
- FDA classified
- 17 Jun 2020
- Reported
- 24 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Pacemakers & Defibrillators
Timeline
| 27 Apr 2020 | Recall initiated by company | |
| 17 Jun 2020 | Classified by FDA | +51 days |
| 24 Jun 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial Number 400101322
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 85702This product is part of a recall event; the main page for the event is DDU-2450 Lifeline ECG recalled by Defibtech.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DDU-2450 Lifeline ECG recalled by Defibtech | Defibtech | Device Malfunction | Nationwide | |
| CLASS II | DDU-2300 Lifeline/ReviveR View recalled by Defibtech | Defibtech | Device Malfunction | Nationwide |
More recalls from Defibtech
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT |
| Device | CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT |
| Device | CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT |
| Device | CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT |
| Device | CLASS II | Semi-Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT |
Other Pacemakers & Defibrillators recalls
All 494| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DermaV Laser System recalled by Lutronic | Lutronic | Other | Nationwide |
| Device | CLASS II | Convenience kits containing select SKUs of Polycarbonate recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled | Medline Industries | Device Malfunction | Nationwide |