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 deaths or serious injuries are reported, 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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7826–7850 of 13683

  • HighFDA (Devices)·Z-0495-2024·2023-12-13

    Integra Cranial Access Kit Recalled for Packaging Defect Compromising Sterility

    Integra LifeSciences is recalling 510 units of Cranial Access Kits due to a defect in outer packaging that can split spontaneously, compromising device sterility and increasing infection risk in neurosurgery.

    Product
    Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2024·2023-12-13

    HVAD Ventricular Assist Device Updated Instructions for Alarm Conditions

    Heartware is providing updated instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and device useful life information for 892 implanted units worldwide.

    Product
    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0467-2024·2023-12-13

    Staar EVO +VISIAN Implantable Collamer Lens Recalled for Specification Compliance Issue

    Staar Surgical is recalling EVO +VISIAN Implantable Collamer Lens devices due to a potential that the devices may not meet specifications. Patients should consult their eye care provider.

    Product
    EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-0488-2024·2023-12-13

    Vyaire Flexible Patient Circuit 3100A Distributed Without U.S. Approval

    Vyaire Medical recalled 188 Flexible Patient Circuit 3100A units distributed in Florida that were approved only for use outside the United States. The circuits were mistakenly distributed in the U.S. market.

    Product
    vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0500-2024·2023-12-13

    Luminex VERIGENE BC-GP Utility Trays Recalled Due to Potential Defects

    Luminex Corporation is recalling 222 kits (4,440 VERIGENE BC-GP Utility Trays) used in blood culture testing due to potentially defective utility trays. The affected lot (062123018C) expires December 20, 2023.

    Product
    Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0479-2024·2023-12-13

    HeartWare HVAD Implant Kit Instructional Update for Fault Alarms

    The FDA is issuing updated instructions for the HeartWare HVAD ventricular assist device to clarify when controller fault alarms sound and when device components should be replaced. No patient harm has been reported.

    Product
    PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0475-2024·2023-12-13

    HVAD Ventricular Assist Device Instructions Updated for Alarm Clarification

    Heartware, Inc. is updating instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and component useful life. The recall affects 45 units distributed worldwide.

    Product
    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0487-2024·2023-12-13

    Remington Medical drainage bags recalled due to packaging label date error

    Remington Medical is recalling drainage bags (Lot 2325111) due to errors in the 'Use by Date' and 'Date of Manufacturer' on box labels. Approximately 3,080 units distributed in PA and FL are affected.

    Product
    Remington MEDICAL Drainage Bag, REF 600-D;
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0506-2024·2023-12-13

    TENS Devices Recalled for Missing Instruction Manual Warnings

    Liberty Medical Solutions is recalling 473 Multi-Mode TENS stimulator units distributed in five states due to missing warnings and contraindications in instruction manuals.

    Product
    Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0470-2024·2023-12-13

    Intraocular Lens Devices May Not Meet Manufacturing Specifications

    Staar Surgical is recalling 3 units of its EVO+VISIAN Implantable Collamer Lens (phakic toric) due to a potential that devices may not meet specifications. No illnesses or injuries have been reported.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-0469-2024·2023-12-13

    EVO VISIAN Intraocular Lens Recalled Due to Specification Concerns

    Staar Surgical Company is recalling EVO VISIAN Implantable Collamer Lens devices due to potential specification defects. Two units distributed across the United States are affected.

    Product
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Devices)·Z-0451-2024·2023-12-13

    Blood Culture Identification Panel Quality Control Test Reporting Issue

    BioFire Diagnostics is recalling BIOFIRE Blood Culture Identification 2 (BCID2) Panels due to instrument characteristic changes that cause Candida tropicalis to be detected but reported as 'Not Detected' in quality control testing.

    Product
    BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0481-2024·2023-12-13

    Ventricular Assist Device Instructions Updated for Alarm and Useful Life Clarification

    Heartware is updating instructions for HVAD ventricular assist device implant kits to clarify Controller Fault alarm conditions and troubleshooting steps, as well as useful life information for system components.

    Product
    PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0414-2024·2023-12-06

    Edwards TruWave pressure monitoring kit recalled for setup issues

    Edwards Lifesciences is recalling 168,014 TruWave with Vamp pressure monitoring kits due to potential flushing difficulties during setup. The recall affects devices distributed across the US and internationally.

    Product
    TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm); PXVK0996:(3cc)/VAMP 68in (174cm); PXVMP2X21: x2 (3cc)/VAMP; PXVMP2X22: x2 (3cc)/VAMP 63 in
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0418-2024·2023-12-06

    Colonoscope Repair Defect May Cause Device Malfunction and Contamination Risk

    Aizu Olympus colonoscopes with improperly repaired light guide connectors may experience loss of image or suction failure. This could delay treatment and expose patients to contaminated material.

    Product
    PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0411-2024·2023-12-06

    FloTrac Sensor Recalled Due to Potential Flushing Difficulties During Setup

    Edwards Lifesciences is recalling 1417 FloTrac Sensors used for intravascular pressure monitoring due to potential flushing difficulties during kit setup. No illnesses or injuries have been reported.

    Product
    FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0402-2024·2023-12-06

    Medical Device Screening Tool Recalled Due to Technical Distortion Issues

    PATH is recalling 28 units of SENTIERO Screening2 hearing examination devices due to potential technical distortions. The affected devices were distributed in Florida, Missouri, Ohio, and Wisconsin.

    Product
    SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0404-2024·2023-12-06

    Medical Device Recall: SENTIERO Hearing Screening Devices for Technical Distortions

    PATH's SENTIERO SCREENING hearing examination devices (Model SOH100098) are being recalled due to technical distortions that may exceed expected levels. The recall affects devices distributed in Florida, Missouri, Ohio, and Wisconsin.

    Product
    SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0422-2024·2023-12-06

    RAPIDPOINT 500e Blood Gas System Recalled Due to Drug Interference

    Siemens RAPIDPOINT 500e blood gas systems may show falsely elevated sodium readings in patients taking Perhexiline Maleate or Atomoxetine, risking misdiagnosis and inappropriate treatment of electrolyte imbalances.

    Product
    RAPIDPOINT 500e Blood Gas System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2024·2023-12-06

    Acumen IQ Sensor Intravascular Pressure Monitor Flushing Difficulty

    Edwards Lifesciences is recalling 33,327 Acumen IQ Sensors used for intravascular pressure monitoring due to potential flushing difficulties during setup. The devices are distributed across the US and internationally.

    Product
    Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0406-2024·2023-12-06

    Da Vinci Needle Driver Recalled for Risk of Dislodgement During Surgery

    Intuitive Surgical is recalling 317 units of a Da Vinci Single-Site Wristed Needle Driver due to potential dislodgement or breakage that could result in uncontrollable movement.

    Product
    Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0405-2024·2023-12-06

    Breas Medical Ventilator Mouthpiece Recall: Unintended Slits May Reduce Ventilation

    Breas Medical is recalling 215 mouthpiece units due to manufacturing defects with unintended slits that may result in insufficient ventilation in mechanical ventilation patients.

    Product
    with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2024·2023-12-06

    Olympus EVIS EXERA III Colonoscope Recall for Connector Defect

    24 Olympus EVIS EXERA III colonoscopes distributed to six states are recalled due to improperly repaired connectors that may cause image loss, decreased suction, or improper reprocessing, potentially exposing patients to contaminated equipment.

    Product
    PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0423-2024·2023-12-06

    RAPIDPOINT 500 Blood Gas System: Drug Interference May Cause False Sodium Readings

    Siemens RAPIDPOINT 500 Blood Gas System may produce falsely elevated sodium results due to drug interference from Perhexiline Maleate or Atomoxetine Hydrochloride. This could lead to missed hyponatremia or inappropriate treatment of hypernatremia.

    Product
    RAPIDPOINT 500 Blood Gas System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0415-2024·2023-12-06

    Olympus colonoscope repair defect may impair imaging and suction function

    Aizu Olympus is recalling 24 colonoscopes with defective repairs to the light guide connector. The defect may prevent proper imaging, reduce suction, and impair device cleaning, potentially exposing patients to contamination.

    Product
    CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states