The Recall Desk

Hazard

Unapproved Feature 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
0
Most recent
2016-09-07

Of the 2 unapproved feature 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 unapproved feature 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

  • ModerateFDA (Devices)·Z-2711-2016·2016-09-07

    Nidek Specular Microscope CEM-530 Software Recall for Unapproved Feature

    Nidek Inc is recalling 29 Specular Microscope CEM-530 units because software versions 1.08 and 1.09 include an unapproved analysis feature.

    Product
    SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelia
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1710-2015·2015-06-10

    Nidek EC-5000 Excimer Laser System Recalled for Unapproved Manual Feature

    Nidek Inc is recalling 114 EC-5000 Excimer Laser Corneal Surgery Systems because the multi-stage treatment option in the operator's manual was not approved by the FDA.

    Product
    EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.
    Category
    Medical Device
    Distribution
    0 states