The Recall Desk

Hazard

Unapproved Change 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
2017-04-19

Of the 2 unapproved change 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 change 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-1755-2017·2017-04-19

    Zimmer Biomet Recalls MEDTECH ROSA Spine Software Due to Unapproved Change

    Zimmer Biomet is recalling MEDTECH ROSA Spine 1.0.2 software because an unapproved change was made by the supplier. The device is used to guide instruments during spine surgery.

    Product
    MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1754-2017·2017-04-19

    Zimmer Biomet Recalls 16 MEDTECH ROSA Brain 3.0 Neurosurgical Devices

    Zimmer Biomet is recalling 16 MEDTECH ROSA Brain 3.0 neurosurgical devices due to an unapproved change made by the supplier.

    Product
    MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is in
    Category
    Medical Device
    Distribution
    Distributed nationwide