The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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16576–16600 of 40248

  • HighFDA (Devices)·Z-2878-2020·2020-09-02

    Ortho VITROS XT3400 Chemistry System Recalled for Erroneous Results

    Ortho Clinical Diagnostics is recalling VITROS XT3400 Chemistry Systems because slides in Slot 18 may be mis-positioned, leading to erroneous test results.

    Product
    VITROS XT3400 Chemistry System, Product code 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2841-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling 2,550 kits of Trans-Ray 7Fr 34cc Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected devices were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2891-2020·2020-09-02

    Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions

    Karl Storz is recalling 2,083 flexible intubation video endoscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide sterilization to avoid introducing infectious agents into patient airways.

    Product
    Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2855-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2881-2020·2020-09-02

    Klarity Vacuum Bags Recalled for Inadequate Vacuum Retention During Radiation Therapy

    Klarity Medical Products LLC is recalling 111 vacuum bags used for patient positioning during radiation therapy because they may not hold a vacuum adequately for the required treatment time.

    Product
    Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2820-2020·2020-09-02

    89 North LDI Laser Firmware Recall for Safety Interlock Defect

    89 North is recalling 188 LDI laser units worldwide due to a firmware defect that allows laser emission to continue when safety interlocks are opened.

    Product
    LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR, LDl-6 Laser Science fluorescence imaging
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2906-2020·2020-09-02

    Neurovision Cobra x5 EMG Endotracheal Tubes Recalled for Insulation Defect

    Neurovision is recalling Cobra x5 EMG endotracheal tubes because the electrode insulation may soften and damage, potentially stopping EMG signal transmission.

    Product
    Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI: B006LTE700DCS52/$$7062618C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2863-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2907-2020·2020-09-02

    Neurovision Cobra x5 EMG ET Tube Recalled for Insulation Softening

    Neurovision is recalling Cobra x5 2-Ch EMG ET Tubes because the electrode insulating material may soften over time, potentially damaging the device and stopping EMG signal transmission.

    Product
    Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2845-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling 6,111 Intra-Aortic Balloon Catheter kits due to potential endotoxin contamination. The affected products were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2865-2020·2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2838-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 1,746 kits distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02, 0684-00-0478-02U - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2860-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2848-2020·2020-09-02

    Siemens Cios Alpha and Spin Mobile X-Ray Systems Recalled for Electrical Malfunction

    Siemens is recalling Cios Alpha and Cios Spin mobile X-ray systems because a hardware error could cause permanent loss of imaging functionality.

    Product
    Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2900-2020·2020-09-02

    Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Defect

    Neurovision is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially stopping EMG signal transmission and rendering the device unusable.

    Product
    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2901-2020·2020-09-02

    Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Defect

    Neurovision Medical Products Inc. is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially stopping EMG signal transmission and rendering the device unusable.

    Product
    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2898-2020·2020-09-02

    Siemens E.cam and Symbia Systems Recalled for Detector Time Loss

    Siemens Medical Solutions is recalling E.cam and Symbia systems with foresight detectors because they may lose detector time information during gated or dynamic acquisitions.

    Product
    E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2849-2020·2020-09-02

    Conformis iTotal Knee Implant Kit Recalled for Incorrect Contents

    Conformis, Inc. is recalling one iTotal CR Knee Replacement kit because the box contained implants and jigs for a different serial number.

    Product
    Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2904-2020·2020-09-02

    Neurovision Cobra EMG ET Tube Recalled for Insulating Material Softening

    Neurovision Medical Products Inc. is recalling Cobra x5 1-Ch EMG ET Tubes because the electrode insulating material may soften, potentially damaging the device and stopping signal transmission.

    Product
    Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2899-2020·2020-09-02

    RayCare Oncology Software Recalled for Offline Image Review Error

    RaySearch Laboratories AB is recalling RayCare oncology software due to an error message that may prevent users from accessing offline images during review tasks.

    Product
    RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2885-2020·2020-09-02

    Canon Medical Ultimax-i Imager Processor Recalled for Image Transfer Errors

    Canon Medical System is recalling 11 Ultimax-i Imager Processors because images transferred to archival systems may not match the number originally acquired.

    Product
    System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2905-2020·2020-09-02

    Neurovision Cobra EMG Endotracheal Tubes Recalled for Insulation Softening

    Neurovision is recalling Cobra x5 1-Ch EMG ET Tubes because the electrode insulating material may soften over time, potentially damaging the device and stopping EMG signal transmission.

    Product
    Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2889-2020·2020-09-02

    BD SafetyGlide Syringes Recalled for Incorrectly Printed Scale Markings

    Becton Dickinson is recalling 3mL SafetyGlide syringes because the printed scale markings are skewed, missing, or partially printed.

    Product
    BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2875-2020·2020-09-02

    Ortho-Clinical Diagnostics Recalls VITROS XT Chemistry TBIL-ALKP Slides

    Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides due to potential interference from etrombopag that may affect total bilirubin test results.

    Product
    VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
    Category
    Medical Device
    Distribution
    Distributed nationwide