DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden ca...
FDA Device Recall #Z-1312-2023 — Class II — February 14, 2023
Recall Summary
| Recall Number | Z-1312-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 14, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Defibtech, LLC |
| Location | Guilford, CT |
| Product Type | Devices |
| Quantity | 29 units |
Product Description
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Reason for Recall
A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
UDI-DI: 00815098020003 Serial Numbers: 101702198 101702263 101702424 101702524 101702535 101702540 101702544 101702545 101703267 101703269 101703272 101703274 101703276 101703277 101703278 101703281 101703312 101703326 101703378 101703407 101703411 101703412 101703419 101703424 101703427 101703464 101703465 101703600 101704106
Other Recalls from Defibtech, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1693-2025 | Class II | Automated External Defibrillators, Model DDU-24... | Mar 18, 2025 |
| Z-1692-2025 | Class II | Automated External Defibrillators, Model DDU-23... | Mar 18, 2025 |
| Z-1694-2025 | Class II | Automated External Defibrillators, Model DDU-22... | Mar 18, 2025 |
| Z-1691-2025 | Class II | Automated External Defibrillators, Model DDU-22... | Mar 18, 2025 |
| Z-1690-2025 | Class II | Semi-Automated External Defibrillators; Models:... | Mar 18, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.