The Recall Desk

Hazard

Lack Of Clearance 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
2
Severe
0
Most recent
2018-09-12

Of the 3 lack of clearance recalls we have scored against our rubric, 2 (67%) 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 lack of clearance 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

  • ModerateFDA (Devices)·Z-2967-2018·2018-09-12

    Encore Medical Recalls Foundation Modular Femoral Stem for Lack of Clearance

    Encore Medical is recalling 12 units of the Foundation Modular Femoral Stem because the device lacks FDA clearance.

    Product
    Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    6 states
  • CriticalFDA (Devices)·Z-2061-2012·2012-08-22

    Stryker Neptune 1 Silver Rover Recalled for Tissue Injury and Fatality

    Stryker is recalling Neptune 1 Silver Rover devices due to reports of serious tissue injury and a fatality, as well as a lack of FDA clearance.

    Product
    Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2064-2012·2012-08-22

    Stryker Neptune Waste Management System Recalled Due to Tissue Injury and Fatality

    Stryker is recalling Neptune waste management systems after reports of serious tissue injury and one fatality. The devices also lack FDA clearance.

    Product
    Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
    Category
    Medical Device
    Distribution
    Distributed nationwide