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DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2...

FDA Device Recall #Z-2394-2020 — Class II — April 27, 2020

Recall Summary

Recall Number Z-2394-2020
Classification Class II — Moderate risk
Date Initiated April 27, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Defibtech, LLC
Location Guilford, CT
Product Type Devices
Quantity 860

Product Description

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) who are: - unconscious and unresponsive, not breathing or not breathing normally.

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 Pattern

Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.

Lot / Code Information

Serial numbers: 400101347 400101348 400101350 400101351 400101364 400101365 400101368 400101371 400101373 400101380 400101381 400101382 400101384 400101385 400101390 400101392 400101395 400101396 400101398 400101399 400101400 400101401 400101402 400101403 400101404 400101405 400101406 400101407 400101408 400101409 400101410 400101411 400101412 400101413 400101414 400101415 400101418 400101419 400101420 400101421 400101422 400101423 400101424 400101425 400101427 400101428 400101429 400101430 400101431 400101432 400101433 400101434 400101435 400101436 400101437 400101438 400101439 400101441 400101442 400101444 400101446 400101447 400101448 400101449 400101451 400101452 400101453 400101454 400101455 400101456 400101457 400101458 400101459 400101460 400101461 400101462 400101463 400101464 400101465 400101466 400101467 400101468 400101469 400101470 400101471 400101472 400101473 400101474 400101475 400101477 400101478 400101480 400101483 400101486

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-1690-2025 Class II Semi-Automated External Defibrillators; Models:... Mar 18, 2025
Z-1691-2025 Class II Automated External Defibrillators, Model DDU-22... 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.

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