The Recall Desk

Hazard

Unapproved Intended Use 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
2024-11-20

Of the 3 unapproved intended use 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 intended use 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-0363-2025·2024-11-20

    Karl Storz Irrigation Tubing Recalled for Unapproved Label Use

    Karl Storz Endoscopy is recalling Irrigation Tubing for the Endomat Select UP210 because its label claims an intended use that the FDA has not approved for U.S. distribution.

    Product
    Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2219-2016·2016-07-27

    WalkMed Infusion Pumps Recalled for Unapproved Software and Specification Changes

    WalkMed Infusion is voluntarily recalling Triton and Triton FP infusion pumps due to unapproved changes to software, specifications, and intended use.

    Product
    The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2220-2016·2016-07-27

    WalkMed Infusion Pumps Recalled for Unapproved Software and Specification Changes

    WalkMed Infusion is recalling Triton and Triton FP infusion pumps due to unapproved changes to software, specifications, and intended use.

    Product
    The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
    Category
    Medical Device
    Distribution
    Distributed nationwide