The Recall Desk

Hazard

Pressure Injury recalls

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

What the numbers show

Total
8
Critical
0
Severe
1
Most recent
2026-08-19

Of the 8 pressure injury recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (13%) 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 pressure injury 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.

1–8 of 8

  • SevereFDA (Devices)·Z-2938-2026·2026-08-19

    Erbe ERBECRYO 2 Cryosurgical Unit Recalled Due to Rupture Risk

    Erbe USA Inc is recalling ERBECRYO 2 Cryosurgical Units because a strong pull on the high-pressure transfer hose may cause the cryoprobe to rupture.

    Product
    ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0696-2025·2024-12-25

    ET Tube Holder Recalled for Risk of Facial Skin Injury

    Medline's HUDSON RCI mBrace ET tube holder is being recalled because its adhesive and frame design may put excessive pressure on patients' cheekbones and upper lip, potentially causing skin injury.

    Product
    HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0698-2025·2024-12-25

    ET Tube Holder Recalled Due to Skin Pressure Defect Risk

    Medline is recalling HUDSON RCI mBrace ET tube holders because defective adhesive and frame can cause pressure on patients' cheeks and lips, risking skin injury. The risk depends on device positioning.

    Product
    HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0695-2025·2024-12-25

    HUDSON RCI mBrace ET Tube Holder Risks Facial Dermal Injury

    Medline is recalling the HUDSON RCI mBrace ET tube holder because defective adhesive and frame elements may cause pressure and skin injury to the face.

    Product
    HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0697-2025·2024-12-25

    Tracheal Tube Holder Recalled for Defect Causing Potential Skin Pressure Injury

    Medline Industries is recalling 1,464 units of the HUDSON RCI mBrace tracheal tube holder due to adhesive and frame defects that may cause skin pressure injury. The device defect puts pressure on patients' cheekbones and upper lip depending on positioning.

    Product
    HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2714-2017·2017-07-19

    ArjoHuntleigh Flowtron ACS900 Medical Pump Recalled for Deflation Failure

    Arjo, Inc. is recalling 40,675 Flowtron ACS900 medical pumps worldwide because the device may fail to deflate the calf garment as intended without triggering an alarm.

    Product
    ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff. Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2017·2017-04-26

    Mizuho Wilson Frame Pads Recalled for Potential Pressure Injury Risk

    Mizuho OSI is recalling 216 Wilson Frame Pads due to a design deficiency that may allow patients to contact the frame's carbon fiber structure, potentially causing pressure injuries.

    Product
    216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are su
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0949-2013·2013-03-20

    Hill-Rom TotalCare SpO2RT2 Bed Recalled for Software Pressure Issue

    Hill-Rom is recalling 309 TotalCare SpO2RT2 beds due to a software defect that may reduce surface cushion pressure, potentially increasing the risk of skin irritation for high-risk patients.

    Product
    TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care
    Category
    Medical Device
    Distribution
    Distributed nationwide