Z-1312-2023Class II

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

Name: Z-1312-2023 DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Creator: Defibtech, LLC
Published: 2023-02-14
License: https://open.fda.gov/license/

Defibtech LLC / initiated 2023-02-14 / Open, Classified / root cause: design

FDA source

Defibtech, LLC began a recall of DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest on 2023-02-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1312-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-14
Posted: 2023-03-30
Recalling firm: Defibtech LLC
Product: DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: design
FDA root cause: Device Design
Action: Defibtech issued Urgent Medical Device Safety Removal User letter (FA2023-01) on 2/14/23 and 2/17/23 via email to Distributors and End-Users. Letter states reason for recall, health risk and action to take: 1. Confirm receipt of this notice by checking the Read receipt option in the email notification containing this communication. Additionally, complete, sign and return to [email protected] the attached Receipt Letter acknowledging that you have received this recall notification 2. Check the box label s 9-digit serial number of any units in your inventory against the serial numbers listed in the attachment 3. It is requested you quarantine the listed AEDs and Defibtech will contact you to arrange their return to Defibtech for screening 4. If you have further transferred the device to another entity or department, you must provide this notice to affected parties Please return any affected units as identified in the Attachment for replacement. Dedicated support for handling all aspects of the return of identified units will be provided by Defibtech. We will be contacting you shortly to help you with the process and answer any questions. If you have questions now, please feel free to contact us using the email address [email protected]. Defibtech Customer Support is available by calling 1-877-453-4507, 8:30 A.M. to 5:30 P.M. (Eastern), Monday - Friday. To assure that you have received notification of this safety issue and understand your obligation in notifying those in possession of the serial number(s) shipped to you or on your behalf of any required action, please sign and return this letter to [email protected].
Quantity in commerce: 29 units
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1312-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1312-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-30

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)