Data Foundry

Medical device recalls 2020

DDU-2400EN Lifeline PRO — Class II medical device recall Z-2393-2020

Terminated recall by Defibtech, LLC, reported 2020-06-24, distributed nationwide. A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affect

Recall numberZ-2393-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmDefibtech, LLC, Guilford, CT, United States
Recall initiated2020-04-27
Classified2020-06-17
Reported by FDA2020-06-24
Terminated2021-01-08
DistributedNationwide (US)
Countries outside the USAE, AU, CA, FR, MY, NL, TH
Quantity860
UPC / GTIN / UDI-DI00815098020270
Serial numbers400101322

Product

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2393-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.