The Recall Desk

Hazard

Tissue Injury recalls

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

What the numbers show

Total
45
Critical
1
Severe
8
Most recent
2026-07-01

Of the 45 tissue injury recalls we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (18%) 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 tissue 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.

1–25 of 45

  • SevereFDA (Devices)·Z-2521-2026·2026-07-01

    Da Vinci surgical system operative components with E-brake retainer pin defect

    Intuitive Surgical recalls certain Da Vinci surgical system operative components due to a defective E-brake retainer pin that may fail to engage the E-brake, potentially causing uncontrolled motion and patient injury.

    Product
    Da Vinci ASSY, PSS, SP1098, Part Number: 380601
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2158-2026·2026-05-20

    Cannon II Plus Hemodialysis Catheter Recall Due to Sheath Introducer Defect

    Arrow International is recalling Cannon II Plus Hemodialysis Catheters due to a defective sheath introducer that may not split properly, potentially causing withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, and tissue injury.

    Product
    Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15242-SPM, CS-15282-SPM, CS-15322-SPM, CS-15362-SPM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2157-2026·2026-05-20

    Arrow-Clark VectorFlow Hemodialysis Catheters with Defective Sheath Introducer

    Arrow International is recalling Arrow-Clark VectorFlow hemodialysis catheters due to a supplier defect in the sheath introducer that may fail to split properly, potentially causing withdrawal resistance, prolonged procedures, pain, bleeding, and tissue injury.

    Product
    Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272-VFI, CS-15272-VFIE, CS-15312-VFI, CS-15312-VFIE, CS-15422-VFI, CS-15422-VFIE, CS-15552-VFI, CS-1555
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2159-2026·2026-05-20

    NextStep Hemodialysis Catheters with Defective Sheath Introducer

    Arrow International is recalling NextStep Antegrade and Retrograde Hemodialysis Catheters worldwide because an included 16F dual-valved splittable sheath introducer may not split as intended, potentially causing pain, bleeding, hematoma, and tissue injury.

    Product
    NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-1523
    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-1781-2025·2025-05-21

    Philips Intera CV MRI Quadrature Body Coil Seal Adhesive Failure Recall

    Philips is recalling Intera CV MRI units (Model 781107) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning, including skin abrasions, lacerations, or tissue damage.

    Product
    Intera CV, Model Number: 781107;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner Quadrature Body Coil Seal Failure

    Philips is recalling the Intera 1.5T Omni/Stellar MRI scanner due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and cause patient injury. The loose seal during scanning could result in skin abrasions, bruises, lacerations, hair loss, or tissue damage.

    Product
    Intera 1.5T Omni/Stellar, Model Number: 781104;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1780-2025·2025-05-21

    Philips Intera 3.0T Quasar Dual MRI Scanner Coil Seal Adhesive Failure

    Philips is recalling the Intera 3.0T Quasar Dual MRI scanner (Model 781150) because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

    Product
    Intera 3.0T Quasar Dual, Model Number: 781150;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2025·2025-05-21

    Philips Intera 1.5T MRI Quadrature Body Coil seal adhesive failure

    Philips is recalling Intera 1.5T MRI systems due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and contact patient skin during scanning.

    Product
    Intera 1.5T, Model Numbers: 781195 and 781295;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1775-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner Quadrature Body Coil Seal Adhesive Failure

    Philips is recalling Intera 1.5T Explorer/Nova Dual MRI scanners (Model 781108) due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges that could contact patients during scanning and cause skin injuries.

    Product
    Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1776-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner Body Coil Seal Failure Recall

    Philips is recalling 103 Intera 1.5T MRI scanners worldwide because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could cause skin abrasions, bruises, lacerations, hair loss, or tissue injury to patients.

    Product
    Intera 1.5T Master/Nova, Model Number: 781106;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1773-2025·2025-05-21

    Philips Intera 1.0T MRI Quadrature Body Coil Seal Failure Recall

    Philips is recalling Intera 1.0T Power/Pulsar MRI systems (Model 781103) due to potential failure of the Quadrature Body Coil seal adhesive, which may create sharp edges and injure patients during scanning.

    Product
    Intera 1.0T Power/Pulsar, Model Number: 781103;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1390-2025·2025-04-02

    Shiley Adult Tracheostomy Tubes Recalled Due to Flange Disconnection Risk

    Covidien is recalling 780 Shiley Adult Flexible Tracheostomy Tubes because the flange may disconnect from the outer cannula, potentially causing respiratory failure, aspiration, or death.

    Product
    Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0679-2025·2024-12-18

    Galaxy Bronchoscope Biopsy Tool Insertion Risk at Sharp Bend Angles

    Noah Medical is recalling Galaxy bronchoscope units due to risk that biopsy tools may require excessive force or fail to pass through the scope channel when the bronchoscope is sharply bent, potentially causing tissue injury or pneumothorax.

    Product
    Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2024·2024-04-17

    da Vinci SP Surgical System Patient Cart Welds May Fail

    Intuitive Surgical recalled 53 da Vinci SP Surgical System Patient Carts due to inadequate welds in the instrument arm joints. These welds may cause tissue injuries, conversion to open surgery, or user pinching injuries.

    Product
    Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-0955-2024·2024-02-07

    Philips MRI Coil Seal Adhesive May Fail and Create Sharp Patient Contact Surfaces

    Philips has recalled certain SmartPath to dStream MRI coil components because the seal adhesive may fail, creating sharp edges that could contact patients during scanning and cause skin and tissue injuries.

    Product
    SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0949-2024·2024-02-07

    Philips Achieva XR MRI Coil Seal Adhesive Failure Risk

    Philips Achieva XR MRI body coil seal adhesive may fail and create sharp edges that could injure patients. Affected units are being recalled.

    Product
    Achieva XR. Model (REF) Numbers 781153, 781253.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0948-2024·2024-02-07

    Philips Achieva 3.0T MRI Coil Seal Adhesive May Fail, Risking Patient Injury

    The Quadrature Body Coil seal adhesive in Philips Achieva 3.0T MRI scanners may fail, creating sharp edges that can injure patients. All units with model numbers 781277, 781177, 781278, 781344, and 781345 are affected.

    Product
    Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0954-2024·2024-02-07

    MRI Machine Coil Seal Adhesive May Create Sharp Edges

    The Intera Achieva 1.5T Pulsar MRI machine's Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients. All units of this model are affected.

    Product
    Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0952-2024·2024-02-07

    Philips MRI Scanner Quadrature Coil Seal Adhesive May Fail and Create Sharp Edges

    Philips Intera 1.5T Achieva Nova MRI machines (Model 781172) may develop seal adhesive failure in the Quadrature Body Coil, creating sharp edges that could injure patients during scanning.

    Product
    Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0950-2024·2024-02-07

    Philips Ingenia MRI Scanner Body Coil Seal Adhesive May Fail

    Philips is recalling Ingenia 1.5T CX MRI scanners because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients. Model numbers 781262 and 781261 are affected.

    Product
    Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0956-2024·2024-02-07

    Philips MRI coil seal adhesive may fail, creating sharp edges and injury risk

    A Philips MRI coil component's adhesive may fail and create sharp edges that could injure patients during scanning. The defect affects 286 units worldwide.

    Product
    SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0953-2024·2024-02-07

    MRI Scanner Quadrature Coil Seal Failure Poses Patient Contact Risk

    Philips is recalling the Intera 1.5T Achieva Nova-Dual MRI scanner due to potential failure of the Quadrature Body Coil seal adhesive. If the seal fails, sharp edges may contact patients, risking skin injuries.

    Product
    Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0643-2024·2024-01-17

    Bard Mission Biopsy Instrument Kits Recalled for Improper Needle-Cannula Fit

    Bard is recalling Mission Disposable Core Biopsy Instrument Kits due to dimensional issues that may prevent the biopsy needle from fitting properly into the cannula, potentially causing tissue injury and prolonging procedures.

    Product
    Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission Ki
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0137-2024·2023-11-01

    Maquet Acrobat-i Cardiac Stabilizer Jaw May Break During Surgery

    The Maquet Acrobat-i Vacuum Stabilizer System's housing mount jaw may break during cardiac surgery, risking injury to heart tissue, blood vessels, or bypass grafts.

    Product
    Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
    Category
    Medical Device
    Distribution
    Distributed nationwide