CLASS II ONGOING Device recall · Reported 7 May 2025 · FDA Enforcement Report
Automated External Defibrillators recalled by Defibtech
Defibtech is recalling Automated External Defibrillators. The recall was initiated on 18 Mar 2025 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-1693-2025
- FDA event ID
- 96618
- Recalling firm
- Defibtech, Guilford, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Mar 2025
- FDA classified
- 29 Apr 2025
- Reported
- 7 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Pacemakers & Defibrillators
Timeline
| 18 Mar 2025 | Recall initiated by company | |
| 29 Apr 2025 | Classified by FDA | +42 days |
| 7 May 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Product as listed by the FDA
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
Where it was distributed
International Only: Switzerland.
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
UDI-DIs: 00815098020317 (DDU-2450, export version), 10815098020314 (DDU-2450, export version (configuration level)). Lot number: 400188859.
Where was it sold?
International Only: Switzerland.
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
3 other products · FDA event 96618This product is part of a recall event; the main page for the event is Semi-Automated External Defibrillators recalled by Defibtech.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Semi-Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT | |
| CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT | |
| CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT |
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 | Semi-Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT |
| Device | CLASS II | DDP-2002: Pediatric Defibrillation Pads For use with AED recalled | 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 |