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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

12376–12400 of 13837

  • SevereFDA (Devices)·Z-0494-2022·2022-02-02

    Trilogy Evo Ventilator Repair Kit Recalled for Degrading Foam Material

    Philips Respironics recalled 205 Trilogy Evo ventilator repair kits containing non-conforming foam material that may degrade into particles potentially inhaled or ingested by users. The affected kits were distributed in the US and internationally.

    Product
    Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric t
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0493-2022·2022-02-02

    Trilogy Evo Ventilator Recalled for Foam Degradation Risk

    Philips Respironics recalls 473 Trilogy Evo ventilators due to non-conforming foam that may degrade and release particles. Affected patients risk inhaling or ingesting foam particles and chemicals during device use.

    Product
    Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adul
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0526-2022·2022-02-02

    Footrest accessory recalled for missing friction rubber block

    FDA recalls Intelli-C footrest accessories due to missing friction rubber blocks in the clamping mechanism. The defect may cause the footrest to slip during use.

    Product
    1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0524-2022·2022-02-02

    GE Vscan Extend ultrasound device recalled for power-on failure due to battery depletion

    GE Healthcare is recalling the Vscan Extend ultrasound device because it will not power on when the battery is depleted. This occurs when 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 Sector Wi-Fi"
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0516-2022·2022-02-02

    Artis icono diagnostic imaging system software defects recalled nationwide

    Siemens is recalling 72 units of Artis icono biplane diagnostic imaging systems nationwide due to four software issues that could disable x-ray capability, corrupt diagnostic images, or cause unexpected shutdowns during procedures.

    Product
    Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-0515-2022·2022-02-02

    Siemens Diagnostic Angiography System Recalled for Multiple Software Defects

    Siemens is recalling its Artis pheno diagnostic angiography system (12 units) due to four software defects that may prevent imaging, corrupt images, or cause unintended shutdowns during clinical use.

    Product
    Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2022·2022-02-02

    API ID 32 C Diagnostic Strips Recalled Due to Thermoforming Defect

    Biomerieux is recalling API ID 32 C Strips due to a thermoforming defect that risks misidentification of yeasts or delayed diagnostic results. The recall affects 462 kits in Arizona, Iowa, Kentucky, and New York.

    Product
    API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either autom
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0528-2022·2022-02-02

    MAGEC 1 System Recalled for Post-Implantation Component Fractures

    The MAGEC 1 System implantable medical device is being recalled due to documented post-implantation fractures of an internal metallic component. The recall affects approximately 3,056 units manufactured before March 26, 2015 and distributed worldwide.

    Product
    MAGEC 1 System
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-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-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-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
  • 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
  • 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-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-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
  • 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-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-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-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