The Recall Desk

Hazard

Delayed Notification recalls

3 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2026-09-09

Of the 3 delayed notification recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all delayed notification recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–3 of 3

  • HighFDA (Devices)·Z-3083-2026·2026-09-09

    Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software

    Boston Scientific is recalling LUX-Dx Insertable Cardiac Monitor server software due to potential delays in Atrial Fibrillation Burden Alert notifications, which may delay clinical evaluation.

    Product
    LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3081-2026·2026-09-09

    Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software

    Boston Scientific is recalling LUX-Dx Insertable Cardiac Monitor server software due to potential delays in Atrial Fibrillation Burden Alerts, which may delay clinical evaluation.

    Product
    LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2023·2022-11-16

    Zio AT Ambulatory ECG Monitoring System Documentation Labeling Update

    iRhythm Technologies is recalling clinical reference materials for the Zio AT cardiac monitoring system due to labeling deficiencies that may delay notification of arrhythmias to healthcare providers. Transmission limits could prevent critical cardiac event reporting.

    Product
    Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
    Category
    Medical Device
    Distribution
    48 states