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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12351–12375 of 13802

  • HighFDA (Devices)·Z-0517-2022·2022-02-02

    Diagnostic Imaging Angiography System Software Defects Recalled by Siemens

    Siemens is recalling 23 Artis icono angiography systems due to four software defects that could disable imaging, corrupt images, and cause unexpected shutdowns during patient procedures.

    Product
    Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0531-2022·2022-02-02

    FlexDex 8mm Needle Driver Damaged Packaging Inspection Guidance

    FlexDex Inc. is reinforcing instructions for the 8mm FlexDex Needle Driver (Product Code FD-335 ND). Users should not use the product if packaging shows any damage, including pinholes or tears.

    Product
    8mm FlexDex Needle Driver, Product Code FD-335 ND
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0519-2022·2022-02-02

    GE Vscan Extend Ultrasound Device May Fail to Power On

    GE Vscan Extend portable ultrasound devices may not power on due to battery depletion caused by improper device handling. The device must be properly turned off before removing the battery or disconnecting from power sources.

    Product
    GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0518-2022·2022-02-02

    GE Vscan Extend ultrasound console fails to power on when battery is depleted

    GE Healthcare is recalling the Vscan Extend ultrasound console due to battery depletion that prevents powering on. The problem occurs when the battery depletes if the device is not turned off before battery removal or is connected to a computer without AC power.

    Product
    GE Vscan Extend, being sold as "Vscan Extend Console"
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0521-2022·2022-02-02

    GE Vscan Extend Ultrasound Devices May Not Power On Due to Battery Depletion

    GE Healthcare is recalling Vscan Extend portable ultrasound devices that may fail to power on due to battery depletion when the device is not turned off before battery removal or before connecting without AC power.

    Product
    GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0522-2022·2022-02-02

    GE Vscan Extend Ultrasound System Recalled for Battery Power Failure

    GE Healthcare is recalling the Vscan Extend portable ultrasound device due to battery power failure. The device may not power on when the battery is depleted, particularly if not turned off before battery removal or when connected to a computer without AC power.

    Product
    GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0523-2022·2022-02-02

    GE Vscan Extend portable ultrasound may not power on due to battery depletion

    GE Healthcare is recalling GE Vscan Extend portable ultrasound devices that may fail to power on if not turned off before battery removal or when connected to a computer without AC power.

    Product
    GE Vscan Extend, being sold as "Vscan Extend Sector USB"
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0520-2022·2022-02-02

    GE Vscan Extend Ultrasound Device Battery Power Failure Recall

    GE Healthcare recalls the Vscan Extend portable ultrasound device because the battery may become depleted and prevent the device from powering on if not turned off before battery removal or when used without AC power.

    Product
    GE Vscan Extend, being sold as "Vscan Extend Dual USB"
    Category
    Medical Device
    Distribution
    50 states
  • CriticalFDA (Devices)·Z-0450-2022·2022-01-26

    Medtronic HawkOne Atherectomy System Recalled for Tip Detachment and Embolization Risk

    Medtronic is recalling the HawkOne Directional Atherectomy System globally due to reports of tip damage that can detach and cause embolization. The device is used to remove arterial plaque in peripheral blood vessels.

    Product
    Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0451-2022·2022-01-26

    Medtronic HawkOne Directional Atherectomy Device Recalled for Tip Damage

    Medtronic is recalling 28,094 units of its HawkOne directional atherectomy system due to reports of catheter tip damage and detachment that can cause blood clots in blood vessels.

    Product
    Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0508-2022·2022-01-26

    Cardinal Infant Heel Warmer recalled due to unapproved labeling changes

    Philips North America recalls Cardinal Infant Heel Warmers because labeling was changed without FDA approval. The devices cannot be sold or distributed without new FDA clearance.

    Product
    Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0502-2022·2022-01-26

    Blood Collection Tubes Recalled Due to Lithium Heparin Variation

    Greiner Bio-One is recalling 889,200 blood collection tubes (Lot #B21053QG) due to variation in lithium heparin that may cause blood clotting. The tubes were distributed to ten U.S. states.

    Product
    greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0512-2022·2022-01-26

    Dental Implant Mislabeling: Neodent Easypack Helix GM Acqua Dimension Error

    Straumann USA LLC recalls Neodent Easypack Helix GM Acqua dental implants due to mislabeling. Implants have incorrect dimensions compared to carton labels, which could affect surgical planning and placement.

    Product
    Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0511-2022·2022-01-26

    Microbiological Reference Products Recalled for Bacterial Contamination

    Microbiologics Inc is recalling KWIK-STIK and LYFO DISK microbiological reference products contaminated with Staphylococcus epidermidis. Fifty-nine kits were distributed to multiple U.S. states and countries.

    Product
    KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0510-2022·2022-01-26

    Voyager Rollator Walkers Recalled for Wheel Separation and Fall Risk

    Compass Health Brands is recalling 3,734 Voyager Rollator walkers due to cracking wheel spokes that may cause wheels to separate from the axle, potentially resulting in patient falls and injuries.

    Product
    Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2022·2022-01-26

    VITROS High Sample Diluent A Reagent Produces Lower Than Expected Results

    Ortho-Clinical Diagnostics is recalling VITROS High Sample Diluent A Reagent Pack Lot 2190 because it produces lower than expected TSH test results. The recall affects 1,416 units distributed worldwide.

    Product
    VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0499-2022·2022-01-26

    FDA Recalls Sensis Cardiac Diagnostic Systems for Software Measurement Error

    Sensis cardiac diagnostic systems used in catheterization and electrophysiology procedures are recalled due to a software error (version VD12A) that can temporarily disable cardiac output measurement. No illnesses have been reported.

    Product
    1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0497-2022·2022-01-26

    Senior Living Nurse Call Systems Failing to Alarm Due to Memory Issue

    Stanley Security Solutions is recalling 11 Senior Living Arial Emergency and Nurse Call Systems because they fail to alarm due to increased memory consumption, potentially preventing nursing staff from responding to resident emergencies.

    Product
    Senior Living Arial Emergency and Nurse Call Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2022·2022-01-26

    Gentueri Viral Transport Medium Recalled Due to Turbidity and Discoloration

    Gentueri Inc is recalling 4,150 units of Gentueri Viral Transport Medium (VTM) nationwide due to visual turbidity and discoloration that may compromise diagnostic samples in transit.

    Product
    Gentueri Viral Transport Medium (VTM), Sterile, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0501-2022·2022-01-26

    Draeger Fabius MRI Anesthesia Machines recalled due to misrouted oxygen hoses

    Draeger Medical recalls 26 Fabius MRI Anesthesia Machines due to incorrectly routed internal oxygen hoses. The misrouting can cause oxygen flow to deviate from set levels, risking inadequate patient oxygenation.

    Product
    Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0513-2022·2022-01-26

    Dental implant kits recalled for mislabeled implant dimensions

    Straumann USA LLC is recalling certain Neodent Easypack dental implant kits due to mislabeling where packaging does not match the implant dimensions inside. Affected units contain 3.5x8mm implants instead of the labeled 3.5x13mm size.

    Product
    Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0514-2022·2022-01-26

    SonarMed AirWave Monitor Kit recall due to alarm and sensor detection failures

    Covidien is recalling 66 SonarMed AirWave Monitor Kits because the alarm may fail to sound and sensors may be incorrectly detected as disconnected, potentially causing the monitor to stop monitoring patients without alerting staff.

    Product
    SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0500-2022·2022-01-26

    ImagePilot diagnostic imaging software versions 1.92 and 1.93 measurement error recall

    Konica Minolta's ImagePilot versions 1.92 and 1.93 software may provide incorrect measurement calculations if improper power sequences are used with AeroDR or Momentum Panel systems.

    Product
    ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0498-2022·2022-01-26

    Medical Device Assay Kits Recalled for Potential Instrument Leakage

    Luminex Corporation is recalling ARIES HSV 1&2 Assay kits due to a potential leak that may occur inside the ARIES diagnostic instrument. No illnesses or injuries have been reported.

    Product
    ARIES HSV 1&2 Assay, Part Number/REF 50-10017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2022·2022-01-26

    Infant Heel Warmers Recalled for Unauthorized Labeling Changes

    Philips North America is recalling 5,164,600 units of Infant Heel Warmers due to labeling changes made after FDA clearance without new approval. The devices cannot be distributed or sold without new FDA 510(k) clearance.

    Product
    Infant Heel Warmers w/strap, Reference # 989805603201 1223
    Category
    Medical Device
    Distribution
    Distributed nationwide