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

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

1351–1375 of 13380

  • LowFDA (Devices)·Z-0895-2026·2025-12-17

    Forza Ti Spacer System Recalled for Labeling Inconsistencies

    Orthofix U.S. LLC is recalling 14,201 units of the Forza Ti Spacer System, a spinal fusion device, due to labeling inconsistencies where claims are not consistently present across affected units.

    Product
    Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H; 38-2009SP F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0892-2026·2025-12-17

    FDA Recalls FORZA PTC Spacer System for Labeling Inconsistencies

    Orthofix U.S. LLC is recalling the FORZA PTC Spacer System due to labeling that contains claims not consistently presented across product materials. The recall affects multiple device models.

    Product
    Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 9H; 38-1010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0586-2026·2025-12-10

    IVENIX INFUSION SYSTEM LVP Primary Administration Set Recalled for Assembly Defect

    Fresenius Kabi is recalling specific lots of IVENIX INFUSION SYSTEM LVP Primary Administration Sets due to incorrect assembly that could result in serious patient injury. The recall affects 483 cases distributed nationwide.

    Product
    IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0790-2026·2025-12-10

    Neurotransmitters Plus Distributed Without FDA Premarket Approval

    Neurotransmitters Plus was distributed nationwide without FDA premarket approval or clearance. Patients should consult their healthcare provider regarding this device.

    Product
    Neurotransmitters Plus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0808-2026·2025-12-10

    Food Intolerance Test Kit Recalled for Unapproved Distribution

    Food Intolerance Test Small by GET TESTED INTERNATIONAL AB was distributed nationwide without required FDA premarket approval or clearance.

    Product
    Food Intolerance Test Small
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0769-2026·2025-12-10

    Allergy Test IgE Distributed Without FDA Premarket Approval or Clearance

    GET TESTED INTERNATIONAL AB is recalling Allergy Test IgE devices distributed nationwide without FDA premarket approval or clearance. The devices were not validated before market distribution.

    Product
    Allergy Test IgE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0756-2026·2025-12-10

    Vitamin D-Test Device Recalled for Distribution Without FDA Approval

    GET TESTED INTERNATIONAL AB is recalling Vitamin D-Test devices distributed without FDA premarket approval or clearance. The unapproved medical devices have not undergone FDA safety and efficacy review.

    Product
    Vitamin D-Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2026·2025-12-10

    IntelliVue Patient Monitor MX800 may fail to alarm

    Philips is recalling IntelliVue Patient Monitor MX800 devices worldwide due to a potential issue where monitors may fail to alarm.

    Product
    IntelliVue Patient Monitor MX800. Product Number: 865240.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0764-2026·2025-12-10

    GI Microbiome Profile XL Distributed Without FDA Premarket Approval

    GET TESTED INTERNATIONAL AB is recalling GI Microbiome Profile XL for distribution without FDA premarket approval or clearance. All lots were distributed nationwide in the United States.

    Product
    GI Microbiome Profile XL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0732-2026·2025-12-10

    Unapproved Diabetes HbA1c Test Recalled for Distribution Without FDA Clearance

    GET TESTED INTERNATIONAL AB is recalling the Diabetes HbA1c Test (all lots) due to distribution without FDA premarket approval or clearance. Approximately 148 units were distributed nationwide.

    Product
    Diabetes HbA1c Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0729-2026·2025-12-10

    Candida Test Recalled for Distribution Without FDA Premarket Approval

    GET TESTED INTERNATIONAL AB is recalling the Candida Test due to distribution without FDA premarket approval or clearance. All 166 units distributed nationwide are affected.

    Product
    Candida Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0759-2026·2025-12-10

    Food Allergy Panel Test Distributed Without FDA Premarket Clearance

    GET TESTED INTERNATIONAL AB has recalled Food Allergy Panel Test kits distributed nationwide because they were marketed without FDA premarket clearance. Consumers should stop using the test and consult their healthcare provider.

    Product
    Food Allergy Panel Test (IgE)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0800-2026·2025-12-10

    Kidney Test Recalled for Distribution Without FDA Premarket Approval or Clearance

    GET TESTED INTERNATIONAL AB recalled its Kidney Test due to nationwide distribution without required FDA premarket approval or clearance. The device's safety and effectiveness were not established before distribution.

    Product
    Kidney Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0728-2026·2025-12-10

    Blood Type Test Recalled for Distribution Without FDA Approval

    GET TESTED INTERNATIONAL AB is recalling its Blood Type Test due to distribution without FDA premarket approval. Consumers who have purchased this product should not use it.

    Product
    Blood Type Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2026·2025-12-10

    GET TESTED Biological Age Test Recalled for Missing FDA Premarket Approval

    GET TESTED INTERNATIONAL AB is recalling its Biological Age & Longevity Test due to distribution without FDA premarket approval. This unapproved diagnostic was distributed nationwide.

    Product
    Biological Age & Longevity Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0850-2026·2025-12-10

    Philips IntelliVue MP5 patient monitors may fail to generate critical alarms

    Philips is recalling IntelliVue MP5 patient monitors that may fail to alarm during patient monitoring. Failure to generate alerts could result in delayed detection of critical patient conditions.

    Product
    IntelliVue MP5. Product Number: M8105A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0851-2026·2025-12-10

    Philips IntelliVue MP20 patient monitors may fail to alarm

    Philips is recalling 1.9 million IntelliVue MP20 patient monitors (Product Number M8001A) worldwide because they may fail to alarm. All serial numbers are affected.

    Product
    IntelliVue MP20. Product Number: M8001A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2026·2025-12-10

    IntelliVue Patient Monitor MX600 may fail to sound alarms

    Philips IntelliVue Patient Monitor MX600 units may fail to sound alarms. Approximately 1.9 million units distributed worldwide; customers should contact Philips.

    Product
    IntelliVue Patient Monitor MX600. Product Number: 865242.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0738-2026·2025-12-10

    Gonorrhea test recalled for distribution without FDA premarket approval

    The FDA is recalling a gonorrhea test that was distributed without required premarket approval and clearance. GET TESTED INTERNATIONAL AB must immediately cease distribution.

    Product
    Gonorrhea test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2026·2025-12-10

    Thyroid TSH Test Recalled for Distribution Without FDA Approval

    GET TESTED INTERNATIONAL AB recalled its Thyroid TSH Test (1916 units, US nationwide) because it was distributed without FDA premarket approval or clearance required for this Class II medical device.

    Product
    Thyroid TSH Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2026·2025-12-10

    IntelliVue Patient Monitor MX400 Recalled for Potential Alarm Malfunction

    Philips is recalling the IntelliVue Patient Monitor MX400 due to a potential issue where alarms may fail to sound. The recall affects approximately 1.9 million units distributed worldwide.

    Product
    IntelliVue Patient Monitor MX400. Product Number: 866060.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0801-2026·2025-12-10

    Unapproved Liver Test Distributed Without FDA Premarket Clearance

    GET TESTED INTERNATIONAL AB's Liver Test was distributed nationwide without FDA premarket approval or clearance. All lots are being recalled due to unapproved distribution.

    Product
    Liver Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0739-2026·2025-12-10

    H. pylori diagnostic test recalled for distribution without FDA approval

    GET TESTED INTERNATIONAL AB is recalling its H. pylori (Peptic Ulcer) Test distributed in the US because it was distributed without FDA premarket approval or clearance. The test was not verified for safety and effectiveness by the FDA before distribution.

    Product
    H pylori (Peptic ulcer) Test
    Category
    Medical Device
    Distribution
    Distributed nationwide