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)

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3201–3225 of 5111

  • SevereFDA (Devices)·Z-2893-2018·2018-08-29

    Philips SureSigns VS3 Vital Signs Monitor Recall for Battery Fire Risk

    Philips is recalling SureSigns VS3 monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing fire and injury risks.

    Product
    Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2892-2018·2018-08-29

    Philips SureSigns VSV Monitors Recalled for Battery Overheating and Ignition Risk

    Philips is recalling SureSigns VSV monitors because lithium-ion batteries may overheat or ignite if not replaced on schedule, posing fire and injury risks.

    Product
    Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric and neonatal patients to gain information for the treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2860-2018·2018-08-29

    Philips DigitalDiagnost Footplate Hook Recall for Injury Risk

    Philips is recalling DigitalDiagnost Rel.4 Upgrades because a defective hook may allow the footplate to fall or swing, potentially injuring patients or operators.

    Product
    DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2894-2018·2018-08-29

    Philips SureSigns VS4 Vital Signs Monitor Recalled for Battery Fire Risk

    Philips is recalling SureSigns VS4 monitors because lithium-ion batteries may overheat or ignite if not replaced on time, posing injury and property damage risks.

    Product
    Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 monitor is for monitoring, recording, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2753-2018·2018-08-29

    Handicare P600 Series Patient Lift Recalled for Strap Wear and Breakage

    Handicare USA Inc. is recalling four P600 Series patient lifts due to premature strap wear and breakage at maximum weight conditions.

    Product
    Handicare P600 Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2844-2018·2018-08-29

    Philips DigitalDiagnost Release 3 Footplate Hook Recall

    Philips is recalling DigitalDiagnost Release 3 units because a defective hook may allow the footplate to fall or swing, posing a risk of injury to patients or operators.

    Product
    DigitalDiagnost Release 3 (Stitching Patient Support) 712025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2811-2018·2018-08-22

    ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold connection.

    Product
    61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2799-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2793-2018·2018-08-22

    NxStage Express Fluid Warmer Recalled for Electrical Fire Risk

    NxStage Medical is recalling Express Fluid Warmers due to a potential risk of electrical fire if fluid leaks into the power receptacle.

    Product
    NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2791-2018·2018-08-22

    Cook Inc. Recalls VentriClear Ventricular Drainage Catheter Sets Due to Endotoxin Failure

    Cook Inc. is recalling 250 units of the VentriClear Ventricular Drainage Catheter Set because the product failed endotoxin testing. The recall involves one distributor in Indiana, and the product was not distributed to end users.

    Product
    VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2589-2018·2018-08-22

    Spacelabs Arkon Anesthesia Delivery System Recalled for Ventilation Failure Risk

    Spacelabs Healthcare is recalling 328 Arkon Anesthesia Delivery Systems because they may stop providing mechanical ventilation while in use or idle.

    Product
    Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating roo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2824-2018·2018-08-22

    Sorin Platinium CRT-D Recall Due to Pacing and Sensing Loss

    Sorin CRM SAS is recalling 16 Platinium CRT-D devices because a hardware defect may cause loss of pacing and sensing, preventing the device from delivering necessary defibrillation.

    Product
    Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2825-2018·2018-08-22

    Sorin Platinium CRT-D Recall Due to Loss of Pacing and Sensing

    Sorin CRM SAS is recalling 10 Platinium CRT-D devices because a hardware issue may cause loss of pacing and sensing, preventing the device from detecting arrhythmias.

    Product
    Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2734-2018·2018-08-15

    Waterpik Sonic-Fusion Professional Recall Due to Charging Base Overheating

    Water Pik, Inc. is recalling 3,797 Waterpik Sonic-Fusion Professional units because the charging base may overheat, melt, or spark, posing fire, shock, or burn risks.

    Product
    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2738-2018·2018-08-15

    Datex-Ohmeda Neonatal Flow Sensor Cable Recall for Missing Connector Housing

    Datex-Ohmeda is recalling 417 Neonatal Flow Sensor Cables because the connector housing may be missing, exposing internal wires. The defect poses a risk of electrical shock or fire.

    Product
    The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2553-2018·2018-08-15

    Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Airflow Obstruction Risk

    Vyaire Medical is recalling 15,714 pediatric AirLife Resuscitation Devices because a manufacturing error may obstruct supplemental oxygen airflow during use.

    Product
    AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric,
    Category
    Medical Device
    Distribution
    28 states
  • SevereFDA (Devices)·Z-2703-2018·2018-08-15

    Howmedica Recalls rHead Radial Head Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 33 rHead Standard Extended Stem implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2716-2018·2018-08-15

    Howmedica Recalls Stryker rHead Radial Head Orthopedic Implants

    Howmedica Osteonics Corp. is recalling 543 units of the #2 Bipolar stem implant from the Stryker rHead system due to higher-than-expected revision rates.

    Product
    #2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2675-2018·2018-08-15

    Howmedica Recalls Stryker Radial Head Implant Assemblies Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 191 Stryker rHead Radial Head implant assemblies because literature reviews indicate a higher revision rate than other similar devices.

    Product
    Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2660-2018·2018-08-15

    Arjohuntleigh Magog Quick Connect 272 KG Scale Recall for Detachment Risk

    Arjohuntleigh Magog is recalling Quick Connect 272 KG Scales used with Maxi Sky 2 ceiling lifts because the spreader bar can detach from the scale attachment.

    Product
    Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or health care facilities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2725-2018·2018-08-15

    Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 256 radial stem implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    radial stem implant #1 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2712-2018·2018-08-15

    Howmedica Recalls #3 Bipolar Radial Head Implant Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 999 units of the #3 Bipolar radial head implant because literature reviews indicate a higher revision rate than other similar devices.

    Product
    #3 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2721-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 118 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant non-coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2685-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate Concerns

    Howmedica Osteonics Corp. is recalling 314 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2717-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 133 rHead Recon Stem Implants because the revision rate is higher than other similar devices, potentially affecting post-surgery performance.

    Product
    rHead Recon Stem Implant non-coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide