The Recall Desk

Hazard

Patient Injury recalls

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

What the numbers show

Total
71
Critical
6
Severe
17
Most recent
2026-09-02

Of the 71 patient injury recalls we have scored against our rubric, 6 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 17 (24%) 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 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 71

  • HighFDA (Devices)·Z-3033-2026·2026-09-02

    IMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk

    IMRIS Imaging Inc is recalling six ORT200 operating room tables because a mechanical failure could cause unintended movement and patient injury.

    Product
    ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2512-2024·2024-08-14

    Baxter Precision Surgical Table Recall: Loose Spring Pins Risk

    Baxter Healthcare Corporation is recalling the PST 500 U Precision Surgical Table due to loose spring pins that can cause the tabletop to unexpectedly tilt or move, potentially causing unintended patient movement during surgery.

    Product
    Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0984-2024·2024-02-14

    Dual Articulating Headrest May Fail to Lock During Surgery

    Steris Corporation is recalling Dual Articulating Headrests that may fail to lock in position during patient procedures, potentially causing patient injury. Affected units were manufactured between August and October 2023.

    Product
    Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2410-2023·2023-08-23

    Phaco Standalone Tips Recalled Due to Plastic Debris Risk

    Alcon is recalling 444,372 units of Phaco Standalone Tips worldwide because the plastic wrench included with the product can generate plastic debris when over-tightened, potentially injuring patients.

    Product
    Phaco Standalone Tips
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2406-2023·2023-08-23

    Alcon Constellation Procedure Pak recalled due to plastic debris risk

    Alcon is recalling the Constellation Procedure Pak due to reports of patient injury from plastic debris. The debris can result from over-tightening the device with the included plastic wrench.

    Product
    Constellation Procedure Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2408-2023·2023-08-23

    Infinity FMS Pak surgical device recalled for plastic debris hazard

    Alcon is recalling the Infinity FMS Pak surgical device after reports of patient injuries during procedures caused by plastic debris from over-tightening the included wrench. The recall affects 51,054 units distributed worldwide.

    Product
    Infinity FMS Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2407-2023·2023-08-23

    Centurion FMS Pak Recalled Due to Patient Injury Risk from Plastic Debris

    Alcon Research recalls the Centurion FMS Pak following reports of patient injury during procedures. Plastic debris can result from over-tightening with the included plastic wrench.

    Product
    Centurion FMS Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0848-2021·2021-01-27

    Penumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage

    Penumbra Inc. is recalling 3,368 JET 7 Reperfusion Catheters because the distal tip may become damaged during use, posing a risk of vessel damage and patient injury or death.

    Product
    Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the ef
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0850-2021·2021-01-27

    Penumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage

    Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.

    Product
    Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0851-2021·2021-01-27

    Penumbra JET 7MAX Kits Recalled for Potential Vessel Damage Risk

    Penumbra Inc. is recalling JET 7MAX Kits because catheter tip damage during use could cause vessel damage, leading to patient injury or death.

    Product
    Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspirat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0849-2021·2021-01-27

    Penumbra JET 7 Reperfusion Catheter Recalled for Potential Vessel Damage

    Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.

    Product
    Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0801-2021·2021-01-13

    Ortho-Clinical VITROS Automation Software Recall for Sample Labeling Errors

    Ortho-Clinical Diagnostics is recalling VITROS Automation Solutions software due to a defect that may cause samples to be mislabeled, potentially leading to incorrect patient results.

    Product
    VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2020·2020-02-12

    Cook Inc. Recalls PTFE Wire Guides Due to Loading Error Risk

    Cook Inc. is recalling 3,929 PTFE Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0961-2020·2020-02-12

    Cook Inc. Recalls Heavy Duty PTFE Wire Guides Due to Loading Error

    Cook Inc. is recalling 146 Heavy Duty PTFE Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0966-2020·2020-02-12

    Cook Inc. Recalls Angled Tip Ureteral Catheter Sets Due to Loading Error

    Cook Inc. is recalling 13,388 Angled Tip Ureteral Catheter Sets because the wire guide may load incorrectly, causing the stiff tip to enter the patient instead of the flexible tip.

    Product
    Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter, Global Product No. G19108 G14587 G15302 G14326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0646-2019·2018-12-26

    Deerfield Imaging Recalls IMRIS ORT 100 Tables Due to Roll Drift

    Deerfield Imaging is recalling 27 IMRIS ORT 100 tables because they may drift in the roll position during use, posing a risk of patient injury.

    Product
    IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3191-2018·2018-09-26

    Swissray Medical Recalls ddR Formula B X-ray Systems for Bucky Movement Risk

    Swissray Medical is recalling 27 ddR Formula B X-ray systems because the bucky component may move unexpectedly, posing a risk of injury to patients.

    Product
    ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2283-2018·2018-07-04

    Siemens ARTIS Pheno X-Ray System Recalled for C-Arm Drop Hazard

    Siemens is recalling 39 ARTIS Pheno Interventional Fluoroscopic X-Ray Systems because the C-arm may drop up to 20 mm, potentially injuring patients.

    Product
    ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1881-2018·2018-05-23

    Visaris Diagnostic X-Ray Systems Recalled for Tube Arm Suspension Failure Risk

    Visaris DOO is recalling 22 diagnostic X-ray systems worldwide due to a potential failure of the tube arm suspension that could cause an uncontrollable descent and patient injury.

    Product
    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1411-2018·2018-04-25

    Philips Brilliance Big Bore CT Systems Recalled for Emergency Stop Defect

    Philips is recalling 119 Brilliance Big Bore CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient load or unload.

    Product
    Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and pla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1409-2018·2018-04-25

    Philips Brilliance iCT SP CT Systems Recalled for Emergency Stop Defect

    Philips is recalling 19 Brilliance iCT SP CT systems because closing the emergency stop may disable the horizontal motor, allowing the couch to move during patient loading.

    Product
    Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1413-2018·2018-04-25

    Philips Brilliance 64 CT System Recalled for Emergency Stop Defect

    Philips Medical Systems is recalling six Brilliance 64 CT systems because closing the emergency stop may disable the horizontal motor, allowing the couch to move during patient loading.

    Product
    Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1414-2018·2018-04-25

    Philips IQon Spectral CT Recalled for Emergency Stop Defect

    Philips is recalling 47 IQon Spectral CT systems because closing the emergency stop may disable the horizontal motor, allowing the couch to move during patient loading.

    Product
    IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devi
    Category
    Medical Device
    Distribution
    Distributed nationwide