The Recall Desk

Hazard

Patient Harm recalls

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

What the numbers show

Total
15
Critical
0
Severe
2
Most recent
2024-12-04

Of the 15 patient harm recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (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 patient harm 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.

1–15 of 15

  • HighFDA (Devices)·Z-0539-2025·2024-12-04

    Philips Breast MRI System Recalled for Patient Safety Risk

    Philips is recalling 5,231 units of the dS Breast 7ch 1.5T breast MRI system due to a potential safety issue that could harm patients during preparation or scanning.

    Product
    dS Breast 7ch 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0546-2025·2024-12-04

    SENSE Breast Coil 3.0T recalled due to potential patient safety hazard

    Philips is recalling approximately 5,231 SENSE Breast Coil 3.0T units due to a potential safety hazard that could harm patients during MRI scanning procedures.

    Product
    SENSE Breast Coil 3.0T 7ch
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2021·2020-12-02

    Mevion Proton Radiation Treatment System Recalled for Screen Display Failure

    Mevion Medical Systems is recalling eight MEVION S250 and S250i proton radiation treatment systems because treatment beam information may disappear from the console screen while the beam continues to deliver.

    Product
    MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0313-2021·2020-11-11

    GE Datex-Ohmeda Aisys CS2 Anesthesia System Recalled for Damaged Flow Sensors

    GE Healthcare is recalling 101 Aisys CS2 Anesthesia Systems because flow sensors may have damaged tubes, posing a risk to patients.

    Product
    GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The device is intended for volume or pressure control ventilation.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1700-2019·2019-06-12

    AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures

    AngioDynamics is recalling 314 Solero Microwave Tissue Ablation System generators to update manuals and software, reducing the risk of patient harm from procedure delays.

    Product
    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2019·2019-06-12

    AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures

    AngioDynamics is recalling 178 Solero Microwave Tissue Ablation System generators to update manuals and software, reducing the risk of patient harm from procedure delays.

    Product
    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2019·2019-06-12

    AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures

    AngioDynamics is recalling 7,348 Solero Microwave Tissue Ablation applicators to update manuals and software, reducing the risk of patient harm from procedure delays.

    Product
    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H787700106002US0 Product Usage: The Solero Microwave Tissue Ablati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2019·2019-06-12

    AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedure Risk

    AngioDynamics is recalling Solero Microwave Tissue Ablation System applicators to reduce the risk of patient harm from delayed procedures via manual and software updates.

    Product
    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 Product Usage: The Solero Microwave Tissue Ablat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1704-2019·2019-06-12

    AngioDynamics Solero Microwave Tissue Ablation System Recall for Procedure Delay Risk

    AngioDynamics is recalling 1,846 Solero Microwave Tissue Ablation System applicators to reduce the risk of patient harm from procedure delays.

    Product
    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue Ablation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1262-2018·2018-04-04

    Allen Medical Systems Recalls F-T3SYSTEM Surgical Table Accessories

    Allen Medical Systems is recalling 83 F-T3SYSTEM surgical table accessories because rail section clamps may fail during use, posing a risk of critical harm to patients.

    Product
    F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2017·2017-01-04

    Medtronic NIM EMG Endotracheal Tubes Recalled for Exposed Wire Hazard

    Medtronic Xomed is recalling NIM EMG Endotracheal Tubes because wire in the tubing can become exposed, posing potential harm to intubated patients.

    Product
    NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0728-2017·2016-12-21

    Prism Medical Carry Bar Recall Due to Breaking Plastic Component

    Prism Medical is recalling carry bars for patient lifts because a black plastic puck may break, posing a risk of harm to patients.

    Product
    Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0652-2016·2016-01-20

    Intuitive Surgical Recalls da Vinci Xi 8mm Endoscopes for Safety Manual Correction

    Intuitive Surgical is correcting the da Vinci Xi I&A User Manual to prevent unintended patient harm from capacitive coupling when using 8mm endoscopes with specific instruments.

    Product
    0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1089-2015·2015-02-18

    Biomet Telluride Percutaneous Rod Inserter Long Recalled for Design Defect

    Biomet Spine is recalling 10 units of the Telluride Percutaneous Rod Inserter Long because the device lacks a locking feature, posing a risk of rod disengagement during surgery.

    Product
    Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0009-2014·2013-10-23

    GE Healthcare Recalls Anesthesia Devices Due to Tidal Volume Overdelivery Risk

    GE Healthcare is recalling specific anesthesia devices because they may deliver excessive tidal volume in a specific ventilation mode, posing a risk of harm to patients.

    Product
    GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide