The Recall Desk

Hazard

Efficacy Uncertainty 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
0
Severe
0
Most recent
2018-05-16

Of the 3 efficacy uncertainty 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 efficacy uncertainty 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-1698-2018·2018-05-16

    Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Changes

    Straumann Manufacturing is recalling Emdogain 0.7 ml Multipacks because a raw material shelf life change was implemented without submitting data to demonstrate continued product efficacy.

    Product
    Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1696-2018·2018-05-16

    Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Changes

    Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf-life change was implemented without submitting data to demonstrate continued product efficacy.

    Product
    Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1693-2018·2018-05-16

    Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Changes

    Straumann Manufacturing is recalling Emdogain Enamel Matrix Derivative because a raw material shelf life change was implemented without submitting data to demonstrate continued product efficacy.

    Product
    Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
    Category
    Medical Device
    Distribution
    Distributed nationwide