The Recall Desk

Hazard

Design Nonconformance 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
2026-01-07

Of the 4 design nonconformance 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 nonconformance 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

  • ModerateFDA (Devices)·Z-1008-2026·2026-01-07

    Laser and endoscopy systems recalled over ferrites omitted from a USB cable

    Beaver-Visitec International is recalling 5 BVI Leos Laser and Endoscopy Systems because ferrites specified for the USB cable assembly were not installed as intended.

    Product
    BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0537-2026·2025-11-26

    Pilot tip converters recalled after release without completed performance testing

    Exactech is recalling one Equinoxe Ergo Augments Pilot Tip Converter because it was released before design updates and performance testing were completed.

    Product
    Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0535-2026·2025-11-26

    Shoulder reamers recalled after release without completed performance testing

    Exactech is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer, 42mm, because it was released before design updates and performance testing were completed.

    Product
    Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0536-2026·2025-11-26

    Shoulder reamer 46mm recalled after release without completed performance testing

    Exactech is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer, 46mm, because it was released before design updates and performance testing were completed.

    Product
    Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
    Category
    Medical Device
    Distribution
    1 state