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 the agency’s own highest classification or reported deaths or serious injuries, 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

21326–21350 of 40175

  • HighFDA (Devices)·Z-0825-2019·2019-02-20

    Hemotherm CE Dual Reservoir Cooler/Heater Recalled for Overheating Risk

    Cincinnati Sub-Zero is recalling 396 Hemotherm CE Dual Reservoir Cooler/Heater units because fuse clips may stretch, causing overheating and device shutdown.

    Product
    Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0834-2019·2019-02-20

    Signature Orthopedics Recalls Three Genius Knee Cemented CR Femoral Components

    Signature Orthopedics is voluntarily recalling three Genius Knee Cemented CR Femoral Components due to a product mix-up. The devices were distributed in Florida, New York, and Tennessee.

    Product
    Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0836-2019·2019-02-20

    Magstim HORIZON Ez Arm Recalled for Protruding Stainless-Steel Cable Strand

    The Magstim Company Limited is recalling 27 HORIZON Ez Arm units because a stray stainless-steel cable strand may protrude from the heat shrink sleeving on the Balance Cable.

    Product
    HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0823-2019·2019-02-20

    Philips Ingenuity TF PET/CT Software Update Corrects Multiple Issues

    Philips is issuing a software update for 24 Ingenuity TF PET/CT systems to correct multiple issues identified in the previous software version.

    Product
    Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0826-2019·2019-02-20

    Ottobock PushValve Recall for Diameter Specification Defect

    Ottobock is recalling 538 PushValve units because some valve inserts have a diameter smaller than the specification. The valve is used for prosthetic fitting of lower limb amputees.

    Product
    21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0833-2019·2019-02-20

    Signature Orthopedics Recalls Genius Knee Cemented Tibial Components Due to Product Mix-Up

    Signature Orthopedics is recalling 10 Genius Knee Cemented Tibial Components due to a product mix-up. The recall covers units distributed in Florida, New York, and Tennessee.

    Product
    Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0828-2019·2019-02-20

    Ottobock MagValve Recall for Prosthetic Socket Air Evacuation Defect

    Ottobock is recalling 110 MagValve units used in prosthetic sockets because some valve inserts have a smaller diameter than specified.

    Product
    21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0827-2019·2019-02-20

    Ottobock PushValve Upper Part Recalled for Diameter Specification Defect

    Ottobock is recalling PushValve upper parts because some installed valve inserts have a diameter smaller than the specification.

    Product
    21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0822-2019·2019-02-20

    Luminex Recalls Verigene BC-GP Utility Kits Due to Labeling Error

    Luminex Corporation is recalling Verigene BC-GP Utility Kits because they were incorrectly labeled with Amplification Tray labels.

    Product
    Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0711-2019·2019-02-13

    Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking

    Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.

    Product
    Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0710-2019·2019-02-13

    Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking

    Smiths Medical is recalling Portex 350 ml Sterile Water Humidifiers because leaking containers may expose patients to infectious agents.

    Product
    Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0715-2019·2019-02-13

    Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking

    Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.

    Product
    Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0722-2019·2019-02-13

    Medline Prefilled 550 ml Sterile Bags Recalled for Leaking

    Medex Cardio-Pulmonary Inc. is recalling 54,924 Medline Prefilled 550 ml Sterile bags due to leaking containers that may compromise sterility.

    Product
    Medline Prefilled 550 ml Sterile¿¿ ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0787-2019·2019-02-13

    CoaguChek XS PT Test Strips Recalled for Abnormally High INR Results

    Terrific Care LLC is recalling CoaguChek XS PT Test Strips sold via MedEx Supply due to potential for abnormally high INR test results.

    Product
    CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0712-2019·2019-02-13

    Smiths Medical Recalls Portex Sterile Water Pour Bottles Due to Leaking

    Smiths Medical is recalling Portex 1000 ml Sterile Water USP Pour Bottles because leaking containers may lack sterility assurance, posing a risk of exposure to infectious agents.

    Product
    Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0719-2019·2019-02-13

    Smiths Medical Recalls Portex Unit Dose Normal Saline Due to Sterility Concerns

    Smiths Medical is recalling Portex Unit Dose 5 ml Normal Saline because leaking containers may lack sterility assurance, posing a risk of exposure to infectious agents.

    Product
    Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0721-2019·2019-02-13

    Smiths Medical Recalls Portex 5ml Normal Saline Units Due to Sterility Issues

    Smiths Medical is recalling 106,000 units of Portex 5ml Normal Saline due to leaking containers that may compromise sterility and expose patients to infectious agents.

    Product
    Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0717-2019·2019-02-13

    Medline Sterile Water Humidifier Recalled for Leaking Containers

    Smiths Medical is recalling Medline sterile water humidifiers because leaking containers may expose patients to infectious agents.

    Product
    Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0718-2019·2019-02-13

    Medline Prefilled 350 ml Sterile Solution Recall Due to Leaking

    Medex Cardio-Pulmonary Inc. is recalling 235,560 units of Medline Prefilled 350 ml Sterile Solution because leaking containers may compromise sterility and expose patients to infectious agents.

    Product
    Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0716-2019·2019-02-13

    Smiths Medical Recalls Intermed 550 ml Sterile Water Humidifiers

    Smiths Medical is recalling Intermed 550 ml Sterile Water Humidifiers due to leaking containers that may compromise sterility and expose patients to infectious agents.

    Product
    Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0720-2019·2019-02-13

    Smiths Medical Recalls Portex Normal Saline Units Due to Sterility Concerns

    Smiths Medical is recalling Portex Unit Dose 15 ml Normal Saline products because leaking containers may compromise sterility, potentially exposing patients to infectious agents.

    Product
    Portex Unit Dose 15 ml Normal Saline ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0802-2019·2019-02-13

    Arjohuntleigh RotoProne Therapy System Recalled for Buckle Release Issue

    Arjohuntleigh is recalling 231 RotoProne Therapy Systems because the proning arm buckle may be difficult to release, potentially delaying emergency patient access.

    Product
    ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0714-2019·2019-02-13

    Smiths Medical Recalls Intermed 350 ml Sterile Water Humidifiers

    Smiths Medical is recalling Intermed 350 ml Sterile Water Humidifiers due to leaking containers that may compromise sterility and expose patients to infectious agents.

    Product
    Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0713-2019·2019-02-13

    Smiths Medical Recalls Portex Sterile Water Pour Bottles Due to Leaking

    Smiths Medical is recalling Portex 500 ml Sterile Water USP Pour Bottles because leaking containers may compromise sterility and expose users to infectious agents.

    Product
    Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0801-2019·2019-02-13

    Radiometer ABL800 FLEX Recalled for Underestimated Creatinine Measurements

    Radiometer America Inc. is recalling ABL800 FLEX analyzers because creatinine measurements may be underestimated by up to 28%, potentially affecting patient safety during radiocontrast x-ray investigations.

    Product
    Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845.
    Category
    Medical Device
    Distribution
    31 states