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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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

7426–7450 of 39968

  • HighFDA (Devices)·Z-1599-2024·2024-05-01

    ACUSON Juniper ultrasound systems display incorrect cardiac measurements

    Siemens ACUSON Juniper ultrasound systems may display the wrong cardiac measurement value when configured to show minimum or maximum values, potentially leading to misdiagnosis.

    Product
    ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1689-2024·2024-05-01

    Baxter Seprafilm Adhesion Barrier Recalled for Unapproved Distribution

    Baxter Healthcare is recalling Seprafilm Adhesion Barrier units (165 units, Lot DBYSEP046) that were distributed nationwide without FDA approval. Affected units distributed in LA, GA, IN, VA, FL, NY, and CA.

    Product
    Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1633-2024·2024-05-01

    3M Durapore Surgical Tape incorrectly labeled with extended shelf life

    Select lots of 3M Durapore Surgical Tape (Catalog Number 1538-118) were labeled with a 5-year shelf life when the actual shelf life is 3 years. The recall affects over 3.5 million rolls distributed worldwide.

    Product
    3M Durapore Surgical Tape, Catalog Number 1538-118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1500-2024·2024-04-24

    Philips Garbin EVO Ventilator False Battery Alarm Causes Ventilation Loss

    Philips Respironics recalls 1,233 Garbin EVO ventilators. A software defect in the battery and power alarm system may cause sudden loss of ventilation despite adequate power supply.

    Product
    Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1499-2024·2024-04-24

    Philips Respironics Aeris EVO Ventilators Recalled for Loss of Ventilation Risk

    Philips Respironics is recalling Aeris EVO ventilators due to a software defect that may cause false battery or power alarms while the device retains adequate power, risking sudden loss of ventilation in pediatric and adult patients. Approximately 775 units are affected.

    Product
    Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1397-2024·2024-04-24

    Elekta Disposable Biopsy Needles Recalled for Microscopic Internal Debris

    Elekta recalled disposable biopsy needles from batch 837838839 that may contain microscopic stainless steel debris inside. The sterility of the needles has not been affected, and this issue has been reported from only one site.

    Product
    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 91
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1501-2024·2024-04-24

    LifeVentEVO2 Ventilator Recalled for Potential Loss of Ventilation

    Philips Respironics is recalling the LifeVentEVO2 ventilator due to a software malfunction that can trigger a false Battery Depleted or Loss of Power alarm when power is sufficient, potentially causing sudden loss of ventilation.

    Product
    LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1504-2024·2024-04-24

    Trilogy Evo Ventilator Recall Due to Potential Loss of Ventilation

    Philips Respironics is recalling the Trilogy Evo ventilator (76,713 units) because it may suddenly stop ventilating when a false Battery Depleted or Loss of Power alarm triggers despite sufficient power available.

    Product
    Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1521-2024·2024-04-24

    FDA Recalls SonarMed Airway Sensor for Obstruction Detection Failure

    SonarMed Inc is recalling the AW-S035 NEO airway monitoring sensor due to failure to detect partial obstructions. The defect may prevent the device from alerting clinicians to airway obstruction.

    Product
    AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-1535-2024·2024-04-24

    Medical Device Airway Monitor Software Defect Prevents Obstruction Detection

    A software anomaly in SonarMed's AW-M0001 airway monitor prevents detection of partial airway obstructions in 2.5mm and larger sensors. The device may fail to alert clinicians to blockages, affecting approximately 145 units across 19 states.

    Product
    AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-1485-2024·2024-04-24

    Tablo Hemodialysis System recalled for PCB contamination in tubing

    Outset Medical is recalling Tablo Hemodialysis Systems because their silicone tubing may contain unremoved polychlorinated biphenyl acids (PCBAs), which could cause skin conditions, liver damage, reproductive harm, or cancer.

    Product
    Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1519-2024·2024-04-24

    SonarMed 2.5mm Airway Sensor Recalled for Obstruction Detection Failure

    SonarMed Inc is recalling the AW-S025 NEO SONARMED SENSOR 2.5MM airway monitoring device due to a malfunction that causes it to fail detecting partial obstruction, potentially preventing clinicians from identifying compromised airways.

    Product
    AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-1502-2024·2024-04-24

    Philips Trilogy EV300 Ventilator False Power Alarm Defect Recall

    Philips is recalling 56,012 Trilogy EV300 ventilators due to a software defect that can trigger a false Battery Depleted or Loss of Power alarm despite adequate power, risking sudden loss of ventilation.

    Product
    Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1520-2024·2024-04-24

    SonarMed Airway Monitoring Sensor Fails to Detect Partial Obstruction

    SonarMed Inc is recalling 690 units of the AW-S030 NEO SONARMED SENSOR because the sensor fails to detect partial airway obstruction. The devices were distributed across 20 US states.

    Product
    AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-1505-2024·2024-04-24

    Philips Trilogy Evo Ventilator Recall: Potential Loss of Ventilation Due to False Alarm

    Philips is recalling the Trilogy Evo Universal Ventilator for a software defect that triggers false low-battery or power-loss alarms despite sufficient power, risking sudden ventilation loss.

    Product
    Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1512-2024·2024-04-24

    Dräger Perseus A500 Anesthesia Workstation Recalled for Unexpected Battery-Power Shutdowns

    Draeger Medical is recalling approximately 16,841 Dräger Perseus A500 Anesthesia Workstations due to unexpected shutdown while operating on battery power. The devices have been distributed nationwide and internationally.

    Product
    Dr¿ger Perseus A500 Anesthesia Workstation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1503-2024·2024-04-24

    Trilogy Evo O2 Ventilator Recalled for Potential Sudden Loss of Ventilation

    Philips Respironics is recalling 789 Trilogy Evo O2 ventilators due to a software defect that can trigger a false power alarm despite sufficient power, potentially causing sudden loss of ventilation in pediatric and adult patients.

    Product
    Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1575-2024·2024-04-24

    Philips MRI Patient Support Table Floor Plate May Be Incorrectly Installed

    Philips is recalling 347 Intera 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed, potentially compromising patient support stability during use.

    Product
    Intera 1.5T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1560-2024·2024-04-24

    Philips GYROSCAN T10-NT MRI Systems Patient Support Table Floor Plate Installation Issue

    Philips North America is recalling GYROSCAN T10-NT MRI systems due to potential incorrect installation of the patient support table floor plate. Affected units should be verified for proper installation.

    Product
    GYROSCAN T10-NT, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1528-2024·2024-04-24

    Peel-Away Introducer medical devices recalled for low packaging seal strength

    Cook Incorporated is recalling 55 Peel-Away Introducers due to packaging with low seal strength that may compromise device sterility.

    Product
    Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1550-2024·2024-04-24

    Philips Achieva 1.5T MRI Systems Recalled Due to Incorrect Support Table Installation

    Philips is recalling 1,921 Achieva 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed. Healthcare facilities should verify proper installation.

    Product
    Achieva 1.5T, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2024·2024-04-24

    Philips Intera 1.5T MRI System Patient Support Table Installation Defect

    Philips is recalling certain Intera 1.5T MRI systems because the patient support table floor plate may be incorrectly installed, which could affect patient safety.

    Product
    Intera 1.5T Omni/Stellar, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2024·2024-04-24

    Philips Achieva 1.5T MRI System: Patient Support Table Floor Plate Installation Issue

    Philips is recalling 69 units of the Achieva 1.5T Initial MRI system due to potential issues with the patient support table floor plate installation, which may affect patient safety during imaging.

    Product
    Achieva 1.5T Initial, Magnetic Resonance System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1526-2024·2024-04-24

    Trocar Needle Recall Due to Packaging Seal Strength Defect

    Cook Incorporated recalled 55 Trocar Needles (Lot 15786588) due to packaging that may not meet peel strength specifications, potentially compromising device sterility. Units were distributed nationwide and internationally.

    Product
    Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G013
    Category
    Medical Device
    Distribution
    Distributed nationwide