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

Agency

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

21401–21425 of 40339

  • 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
  • HighFDA (Devices)·Z-0820-2019·2019-02-13

    Bone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue

    Angiotech is recalling 504 bone marrow biopsy needles due to a manufacturing issue affecting the sterile seal on blister trays.

    Product
    Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2019·2019-02-13

    Angiotech Recalls Bone Marrow Biopsy Needles Due to Sterile Seal Defect

    Angiotech is recalling specific lots of bone marrow biopsy needles because a manufacturing issue may have compromised the sterile seal on the blister trays.

    Product
    "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0776-2019·2019-02-13

    GE Healthcare Recalls Revolution CT Systems with SmartStep Option

    GE Healthcare is recalling 131 Revolution CT systems with the SmartStep Option because the displayed Z location may not match the actual table position, potentially causing scans at incorrect locations.

    Product
    Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0797-2019·2019-02-13

    Handpiece Headquarters Recalls Henry Schein CU 1000 Halogen Curing Lights

    Handpiece Headquarters is recalling 252 Henry Schein CU 1000 Halogen Curing Lights because the tip became too hot, causing heat sensations in patients.

    Product
    Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0817-2019·2019-02-13

    Bone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue

    Angiotech is recalling 500 units of Double Diamond J Type Bone Marrow Needles due to a manufacturing defect in the sterile seal on blister trays.

    Product
    Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2019·2019-02-13

    Angiotech Recalls Bone Marrow Needles Due to Sterile Seal Manufacturing Issue

    Angiotech is recalling 180 units of J Type Bone Marrow Needles due to a manufacturing issue affecting the sterile seal on blister trays.

    Product
    J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2019·2019-02-13

    GE Healthcare Recalls Centricity Universal Viewer Breast Imaging Software

    GE Healthcare is recalling Centricity Universal Viewer Breast Imaging software because a display error could lead to incorrect patient diagnoses.

    Product
    GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0800-2019·2019-02-13

    Bard SureStep Foley Tray System Recalled for Potential Sample Port Leaks

    Bard Medical Division is recalling 450 units of SureStep Foley Tray Systems because the sample ports may leak urine.

    Product
    BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0798-2019·2019-02-13

    Abbott Recalls Free T3 Reagent Kits Due to Carryover Issues

    Abbott Ireland Diagnostics Division is recalling ARCHITECT Free T3 Reagent Kits because reagent carryover may cause depressed test results on specific platforms.

    Product
    ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0804-2019·2019-02-13

    Richard Wolf Bronchoscope Tubes Recalled for Potential Bonding Defects

    Richard Wolf GmbH is recalling 873 Bronchoscope Tubes, Model Texas, because non-functional bonding points may loosen. The devices are used for respiratory tract investigation and therapy.

    Product
    Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0796-2019·2019-02-13

    Medtronic CareLink Encore 29901 Programmer Recalled for Usage Restrictions

    Medtronic is recalling CareLink Encore 29901 programmers to ensure they are used only for Medtronic or Vitatron implantable devices by trained personnel.

    Product
    MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0815-2019·2019-02-13

    Angiotech Recalls Bone Marrow Biopsy Needles Due to Sterile Seal Defect

    Angiotech is recalling 1,260 bone marrow biopsy needles due to a manufacturing issue affecting the sterile seal on blister trays.

    Product
    J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
    Category
    Medical Device
    Distribution
    Distributed nationwide