CLASS II ONGOING Device recall · Reported 7 May 2025 · FDA Enforcement Report
Automated External Defibrillators recalled by Defibtech
Defibtech is recalling Automated External Defibrillators, distributed nationwide in the US. 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-1691-2025
- 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-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
Where it was distributed
International Only: Switzerland.
Questions about this recall
Is Automated External Defibrillators recalled?
Yes. Defibtech recalled Automated External Defibrillators on 18 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1691-2025.
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; 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,
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Defibtech
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | Nationwide |
| Device | CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | CT |
| Device | CLASS II | Automated External Defibrillators recalled by Defibtech | Defibtech | Other | Nationwide |
| Device | CLASS II | Semi-Automated External Defibrillators recalled by Defibtech | Defibtech | Other | Nationwide |
| Device | CLASS II | DDP-2002: Pediatric Defibrillation Pads For use with AED recalled | Defibtech | Lead & Heavy Metals | CT |
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