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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6676–6700 of 13666

  • HighFDA (Devices)·Z-1624-2024·2024-05-01

    TRIDENTII HEMI hip prosthesis recalled for manufacturing defect

    Howmedica Osteonics is recalling TRIDENTII HEMI CLUSTER52E hip prostheses due to excessive deburring on the acetabular shell. The defect may increase risk of hip dislocation in high-risk patients.

    Product
    TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1601-2024·2024-05-01

    Diagnostic Ultrasound System Displays Incorrect Cardiac Values During Measurement Export

    ACUSON Maple ultrasound systems display the last cardiac measurement value instead of the configured minimum or maximum, potentially causing patient misdiagnosis during cardiac assessment.

    Product
    ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2024·2024-05-01

    Pedicle Screw Heads Recalled Due to Cross-Threading Risk During Surgery

    SeaSpine's Mariner RDX MIS pedicle screw heads may have partial threading that causes cross-threading at the screw head interface during implant installation. Affected units distributed in CA, FL, CO, and TX.

    Product
    Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1602-2024·2024-05-01

    Abbott Alinity m System camera generates error with certain tubes

    Abbott Molecular is recalling 1,012 Alinity m System units due to a camera detection issue that generates an error message when certain third-party transport medium tubes lack a sample rack retention bar.

    Product
    Alinity m System, Part Number: 08N53-002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1628-2024·2024-05-01

    Hip implant recalled for acetabular shell deburring defect

    Howmedica Osteonics Corp. is recalling TRIDENTII PSL CLUSTER48D hip implants (Lot 16311453) due to excessive deburring on the acetabular shell edge, a manufacturing defect.

    Product
    TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1632-2024·2024-05-01

    Hip replacement acetabular shells recalled for deburring defect

    Howmedica is recalling hip replacement acetabular shells that may have excessive deburring, resulting in a smooth surface on the shell edge. The recall affects devices distributed nationwide and internationally.

    Product
    TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2024·2024-05-01

    Replacement Lead Wires Recalled for Risk of Treatment Delivery Failure

    EBI, LLC recalls 829 replacement lead wire assemblies (Part 1067724-2) distributed nationwide since May 1, 2023. Damaged wire sheaths may prevent therapeutic treatment signals from reaching electrodes, potentially delaying treatment.

    Product
    20" Lead Wires, Replacement Part Number: 1067724-2
    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-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
  • 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-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-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-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-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-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-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-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-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-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-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-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-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
  • HighFDA (Devices)·Z-1597-2024·2024-04-24

    RENASYS EDGE 800ML Canister Recalled for Carbon Filter Damage Risk

    Smith & Nephew is recalling RENASYS EDGE 800ML canisters due to black particulate matter from the carbon filter potentially damaging the NPWT pump. Affected patients should contact their healthcare provider.

    Product
    RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
    Category
    Medical Device
    Distribution
    Distributed nationwide