CLASS II ONGOING Device recall · Reported 5 Apr 2023 · FDA Enforcement Report

DDU-100 Lifeline Automated External Defibrillator recalled by Defibtech

Defibtech is recalling DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of, distributed nationwide in the US. The recall was initiated on 14 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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

Quantity recalled29 units

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-1312-2023
FDA event ID: 91799
Recalling firm: Defibtech, Guilford, CT
Classification: Class II
Status: Ongoing
Recall initiated: 14 Feb 2023
FDA classified: 30 Mar 2023
Reported: 5 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

14 Feb 2023	Recall initiated by company
30 Mar 2023	Classified by FDA	+44 days
5 Apr 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

US Nationwide distribution.

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.

More recalls from Defibtech

All 14

Reported	Class	Recall	Company	Reason	Where
7 May 2025Device	CLASS II	Automated External Defibrillators recalled by Defibtech	Defibtech	Other	CT
7 May 2025Device	CLASS II	Automated External Defibrillators recalled by Defibtech	Defibtech	Other	CT
7 May 2025Device	CLASS II	Automated External Defibrillators recalled by Defibtech	Defibtech	Other	CT
7 May 2025Device	CLASS II	Automated External Defibrillators recalled by Defibtech	Defibtech	Other	CT
7 May 2025Device	CLASS II	Semi-Automated External Defibrillators recalled by Defibtech	Defibtech	Other	CT

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