The Recall Desk

Hazard

Device Size Mismatch 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
2022-10-12

Of the 3 device size mismatch 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 device size mismatch 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-0005-2023·2022-10-12

    Wright Medical EVOLVE Proline Stem Labeling Error Recall

    Wright Medical is recalling EVOLVE Proline Stem devices due to labeling errors where the outer package does not match the device inside. Affected devices are size-mismatched, which could lead to incorrect surgical placement.

    Product
    stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0729-2022·2022-03-16

    Vascular Graft Mislabeled; Packaging Labels Do Not Match Product Specifications

    A vascular graft has been recalled due to labeling mismatch: the outer package label differs from the inner sterile packaging in graft type and dimensions. Implanting the wrong size could disrupt blood vessel connections and create a pseudo-aneurysm.

    Product
    HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2021·2021-08-18

    Endoscope Grasper/Retriever Devices Mislabeled with Incorrect Catalog Numbers

    Shent USA recalls grasper/retriever endoscopy devices that are mislabeled with incorrect catalog numbers. Units labeled as catalog #7208 may actually be #7226 and vice versa, potentially causing use of the wrong jaw size.

    Product
    Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide