The Recall Desk

Hazard

Design Control Failure 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
2022-04-13

Of the 3 design control failure 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 design control failure 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

  • HighFDA (Devices)·Z-0890-2022·2022-04-13

    Customized Brius orthodontic devices recalled for design control failure

    Brius Technologies is recalling 13 customized metal orthodontic appliances that were sold and distributed prior to completing the required design control process and documentation.

    Product
    Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0889-2022·2022-04-13

    Brius Patient Specific Brackets recalled without completing design control process

    Brius Technologies is recalling Brius Patient Specific Brackets that were sold before the company completed the required design control process and regulatory documentation.

    Product
    Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1632-2014·2014-05-28

    SCM True Air Technologies Recalls MaXair Mattress Replacement Systems

    SCM True Air Technologies is recalling 83 MaXair True Low Air Loss Mattress Replacement Systems due to design control and documentation deficiencies.

    Product
    MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide