The Recall Desk

Hazard

Unvalidated Design recalls

4 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2018-05-23

Of the 4 unvalidated design 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 unvalidated design 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.

1–4 of 4

  • HighFDA (Devices)·Z-1872-2018·2018-05-23

    Kelyniam Custom Skull Implant Recall for Unvalidated Design Changes

    Kelyniam Global is recalling 23 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for clearance.

    Product
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2018·2018-05-23

    Kelyniam Custom Skull Implant Recalled for Unvalidated Design Changes

    Kelyniam Global is recalling 54 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for clearance.

    Product
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2018·2018-05-23

    Kelyniam Custom Skull Implant Recalled for Unvalidated Design Changes

    Kelyniam Global is recalling two Custom Skull Implants because significant design changes were not validated or submitted to the FDA for marketing clearance.

    Product
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2018·2018-05-23

    Kelyniam Custom Skull Implant Recalled for Unvalidated Design Changes

    Kelyniam Global is recalling 16 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for marketing clearance.

    Product
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
    Category
    Medical Device
    Distribution
    Distributed nationwide