The Recall Desk

Hazard

Unintended Energy Delivery recalls

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

What the numbers show

Total
4
Critical
0
Severe
1
Most recent
2024-10-30

Of the 4 unintended energy delivery recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (25%) 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 unintended energy delivery 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.

1–4 of 4

  • HighFDA (Devices)·Z-0135-2025·2024-10-30

    Olympus Soltive Pro Laser Systems Recalled for Incorrect Bladder Stone Translation

    Olympus is recalling Soltive Pro SuperPulsed Laser Systems because the term 'Bladder Stone' was incorrectly translated as 'Kidney Stone' in Spanish and Portuguese, posing a risk of unintended energy delivery.

    Product
    Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0202-2019·2018-10-31

    Boston Scientific Recalls Maestro 4000 Cardiac Ablation Systems Due to RF Energy Issue

    Boston Scientific is recalling Maestro 4000 Cardiac Ablation Systems because radiofrequency energy may continue to deliver after the foot switch is released.

    Product
    Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0210-2018·2017-12-13

    Biosense Webster Recalls SMARTABLATE RF System Generator Units

    Biosense Webster is recalling 185 SMARTABLATE RF System Generators because they may inadvertently deliver RF energy if the foot pedal is placed near Stereotaxis magnets.

    Product
    SMARTABLATE RF System Generator
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1691-2015·2015-06-03

    Biosense Webster Recalls SMARTABLATE RF Generator Systems Due to Unintended Energy Delivery

    Biosense Webster is recalling 115 SMARTABLATE RF Generator Systems because two complaints reported the device inadvertently delivered RF energy during procedures.

    Product
    SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation p
    Category
    Medical Device
    Distribution
    Distributed nationwide