The Recall Desk

Hazard

Sizing Mismatch 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
2023-11-08

Of the 4 sizing 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 sizing 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.

1–4 of 4

  • HighFDA (Devices)·Z-0214-2024·2023-11-08

    Unity Total Knee System Inserts May Be Mislabeled With Wrong Size

    Corin Ltd is recalling Unity Total Knee System inserts due to a labeling mix-up between batches 529803 and 532405, potentially affecting size 6 and size 7 designations.

    Product
    Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2394-2023·2023-08-16

    HoverMatt air transfer mattress contains undersized unit, increases injury risk

    Stryker's HoverMatt 39-inch inflatable transfer mattresses contain 34-inch units inside, reducing available support surface. This increases friction during patient transfers and raises the risk of skin tears.

    Product
    HoverMatt, 39" W x 78" L, REF: HM39SPU-B
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0388-2022·2021-12-22

    Flexor Check-Flo Introducer Recalled for Mislabeled Caliber Size

    Cook Inc. is recalling Flexor Check-Flo Introducer devices due to mislabeling where packages marked as 6FR may contain 7FR devices, or vice versa. This sizing mismatch could result in improper device selection during clinical vascular procedures.

    Product
    Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2348-2021·2021-09-01

    Orthopedic knee replacement stem: wrong size provided in mislabeled packaging

    DePuy Orthopaedics recalled 7 units of ATTUNE REVISION CEMENTED STEM (16×80mm) because packages labeled as 16×80mm contained 16×130mm stems instead. This size mismatch could cause improper implantation if not caught before surgery.

    Product
    ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
    Category
    Medical Device
    Distribution
    0 states