The Recall Desk

Hazard

Skin Injury recalls

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

What the numbers show

Total
21
Critical
0
Severe
8
Most recent
2025-05-21

Of the 21 skin 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 8 (38%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all skin 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.

1–21 of 21

  • HighFDA (Devices)·Z-1782-2025·2025-05-21

    Philips SmartPath dStream 1.5T MRI coil may create sharp edges

    Philips is recalling SmartPath to dStream 1.5T MRI units (Model 782146) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could cause skin abrasions, lacerations, or tissue injury to patients.

    Product
    SmartPath to dStream for 1.5T, Model Number: 782146;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner QBC Seal Adhesive Failure Risk

    Philips is recalling the Intera 1.5T Power/Pulsar MRI scanner because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

    Product
    Intera 1.5T Power/Pulsar, Model Number: 781105;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2025·2025-05-21

    Philips Intera 1.0T MRI System Quadrature Body Coil Seal Adhesive Failure

    Philips is recalling Intera 1.0T Omni/Stellar MRI systems (37 units: 3 in US, 34 internationally) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that can cause skin injuries during patient scanning.

    Product
    Intera 1.0T Omni/Stellar, Model Number: 781102;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1771-2025·2025-05-21

    Philips Intera 0.5T Standard MRI System Quadrature Body Coil Seal

    Philips is recalling the Intera 0.5T Standard MRI system (Model 781101) because the Quadrature Body Coil seal adhesive may fail and create sharp edges that could injure patients during scanning.

    Product
    Intera 0.5T Standard, Model Number: 781101;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1338-2023·2023-04-12

    Moberg CNS-350 Neuromonitoring System Recalled for Battery Leakage Risk

    Moberg is recalling 89 CNS-350 Neuromonitoring System devices due to battery leakage that can corrode the metal enclosure, potentially causing skin injury. Affected units were distributed worldwide.

    Product
    Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0263-2023·2022-11-30

    3M Steri-Drape Surgical Drape Recall for Adhesive Defect and Skin Injuries

    3M is recalling 554,200 surgical drapes due to a difficult-to-remove adhesive liner that may damage the product and render it unusable. The company has received reports of adhesive-related skin injuries from the affected lots.

    Product
    3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0249-2023·2022-11-30

    3M Steri-Drape surgical drapes recalled for skin injuries and adhesive damage

    3M is recalling 248,750 Steri-Drape surgical drapes used in medical facilities worldwide. The adhesive liner is difficult to remove without damaging the product, and there are reported increases in adhesive-related skin injuries.

    Product
    3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0261-2023·2022-11-30

    3M Steri-Drape surgical drapes recalled due to adhesive skin injuries

    3M is recalling 103,000 units of Steri-Drape surgical drapes worldwide due to difficulties removing the adhesive liner and an increase in reported skin injuries from the adhesive.

    Product
    3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0264-2023·2022-11-30

    3M Urological Drape: Adhesive Liner Removal Issues and Skin Injuries

    3M has recalled 17,200 units of urological drapes due to adhesive liner removal difficulty and reported skin injuries. The affected drapes may become unusable in surgical settings.

    Product
    3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0247-2023·2022-11-30

    3M Steri-Drape surgical drape with defective adhesive liner recalled

    3M is recalling Steri-Drape Small Towel Drapes because the adhesive liner is difficult to remove without damaging the product and has caused reported skin injuries.

    Product
    3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0506-2019·2018-12-05

    NxStage PureFlow B Solution Recalled Due to Bag Bursting Risk

    NxStage Medical is recalling 7,275 units of PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0502-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Bursting and Injury

    NxStage Medical is recalling specific lots of PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0505-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Bursting

    NxStage Medical is recalling PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0507-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Bursting Hazard

    NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0501-2019·2018-12-05

    NxStage PureFlow B Solution Recalled Due to Bag Burst Risk

    NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may injure eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Burst Injury Risk

    NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2019·2018-12-05

    NxStage PureFlow B Solution Recalled Due to Bag Burst Risk

    NxStage Medical is recalling 2,189 units of PureFlow B Solution because the bag's smaller chamber can burst, releasing electrolyte fluid that may injure eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1921-2017·2017-05-10

    Roho Sensor Ready Cushions Recalled for Improper Setup Risk

    Roho Inc. is recalling 5,646 units of ROHO High and Mid Profile cushions because the Smart Check tool may cause improper inflation, increasing the risk of skin or soft tissue injury.

    Product
    ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2013·2013-08-07

    Sotera Wireless Recalls ViSi Mobile Monitor Due to Blister Wound Risk

    Sotera Wireless is recalling 90 ViSi Mobile Monitoring Systems because the chest sensor may cause blister wounds.

    Product
    ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1818-2013·2013-08-07

    Sotera Wireless Recalls ViSi Mobile Chest Sensors for Blister Risk

    Sotera Wireless is recalling 75 ViSi Mobile Chest Sensors because they may cause blister wounds on patients.

    Product
    ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
    Category
    Medical Device
    Distribution
    2 states