Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91799

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 14, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Defibtech, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1312-2023
Recall number
Z-1312-2023
Initiated
February 14, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Defibtech, LLC
Quantity
29 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

US Nationwide distribution.