The Recall Desk

Hazard

Insulation Breach recalls

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

What the numbers show

Total
2
Critical
0
Severe
2
Most recent
2013-09-04

Of the 2 insulation breach recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (100%) 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 insulation breach 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.

1–2 of 2

  • SevereFDA (Devices)·Z-2097-2013·2013-09-04

    Megadyne Recalls E-Z Clean Laparoscopic Electrodes Due to Insulation Breach

    Megadyne Medical Products is recalling specific lots of E-Z Clean Disposable Laparoscopic Electrodes due to potential insulation breaches.

    Product
    E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0928-2013·2013-03-20

    Sorin Isoline Implantable Defibrillation Leads Recalled for Insulation Breach

    Sorin Group USA is recalling 1,376 Isoline implantable defibrillation leads due to potential internal insulation breaches. The leads are used for treating life-threatening heart arrhythmias.

    Product
    Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
    Category
    Medical Device
    Distribution
    Distributed nationwide