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

Category

Minimum severity

Clear filters

1376–1400 of 13380

  • HighFDA (Devices)·Z-0789-2026·2025-12-10

    Neurotransmitters Basic Medical Device Recalled for Lack of FDA Clearance

    GET TESTED INTERNATIONAL AB is recalling the Neurotransmitters Basic medical device for distribution without FDA premarket approval. The device was marketed nationwide without required regulatory clearance.

    Product
    Neurotransmitters Basic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0735-2026·2025-12-10

    Epstein-Barr Virus Test Recalled for Distribution Without FDA Approval

    GET TESTED INTERNATIONAL AB is recalling 4,081 units of an Epstein-Barr Virus test that was distributed nationwide without FDA premarket approval. The recall affects all lots of this diagnostic test.

    Product
    Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2026·2025-12-10

    Philips IntelliVue MP90 Monitors May Fail to Activate Patient Alarms

    Philips is recalling IntelliVue MP90 patient monitors worldwide due to a potential issue where monitors may fail to activate alarms, preventing healthcare providers from receiving critical patient alerts.

    Product
    IntelliVue MP90. Product Number: M8010A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0750-2026·2025-12-10

    Sperm Test Distributed Without FDA Premarket Clearance

    A sperm test from GET TESTED INTERNATIONAL AB (33 units, nationwide US distribution) was recalled for being distributed without FDA premarket approval or clearance.

    Product
    Sperm Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0804-2026·2025-12-10

    Unapproved allergy test distributed without FDA clearance

    GET TESTED INTERNATIONAL AB distributed 76 units of its Allergy test Small product nationwide without FDA premarket approval or clearance.

    Product
    Allergy test Small
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0775-2026·2025-12-10

    Candida Test distributed without FDA premarket approval or clearance

    GET TESTED INTERNATIONAL AB recalled a Candida Test distributed nationwide without FDA premarket approval or clearance. Consumers should stop using the product and consult their healthcare provider.

    Product
    Candida Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2026·2025-12-10

    Parasite Test Recalled for Distribution Without FDA Premarket Approval

    GET TESTED INTERNATIONAL AB's Parasite Test is being recalled because it was distributed without required FDA premarket approval or clearance. All 94 units distributed nationwide should not be used.

    Product
    Parasite Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0852-2026·2025-12-10

    IntelliVue MP30 patient monitors recalled for potential alarm failure

    Philips is recalling 1.9 million IntelliVue MP30 patient monitors worldwide due to a potential issue where monitors did not alarm, which could prevent healthcare providers from receiving alerts.

    Product
    IntelliVue MP30. Product Number: M8002A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0847-2026·2025-12-10

    Welch Allyn Blood Pressure Cuff Replacement Bladders May Have Wrong Size

    Baxter Healthcare is recalling Welch Allyn replacement bladders for two-piece blood pressure cuffs due to incorrect sizing. Some kits may contain a Large Adult bladder instead of the intended Thigh size, potentially resulting in inaccurate blood pressure readings.

    Product
    Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2026·2025-12-10

    Organic Acids Profile Test Large Recalled for Unapproved Distribution

    GET TESTED INTERNATIONAL AB is recalling the Organic Acids Profile Test Large because it was distributed in the United States without FDA premarket approval or clearance. All lots are affected.

    Product
    Organic Acids Profile Test Large
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0727-2026·2025-12-10

    Saliva Alcohol Test Distributed Without FDA Premarket Approval

    Alcohol saliva test from GET TESTED INTERNATIONAL AB was distributed nationwide without FDA premarket approval or clearance. The device's safety and accuracy were never verified before market distribution.

    Product
    Alcohol (ALC) Test Saliva
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0867-2026·2025-12-10

    Philips IntelliVue Patient Monitor MX700 May Fail to Alarm

    Philips is recalling IntelliVue Patient Monitor MX700 units due to a potential issue where monitors may fail to alarm. The recall affects approximately 1.9 million units distributed worldwide.

    Product
    IntelliVue Patient Monitor MX700. Product Number: 865241.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0754-2026·2025-12-10

    Urinary Tract Infection Test Recalled for Unapproved Distribution

    GET TESTED INTERNATIONAL AB recalled its Urinary Tract Infection Test because the device was distributed without FDA premarket approval or clearance. No illnesses have been reported.

    Product
    Urinary Tract Infection Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0786-2026·2025-12-10

    Lactose Intolerance Test Recalled for Distribution Without FDA Premarket Approval

    GET TESTED INTERNATIONAL AB is recalling the Lactose Intolerance Test due to distribution without FDA premarket clearance. The product was distributed nationwide without required regulatory approval.

    Product
    Lactose Intolerance Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2026·2025-12-10

    Philips IntelliVue Patient Monitor MX850 may fail to alarm

    Philips is recalling IntelliVue Patient Monitor MX850 due to potential alarm failures affecting 1.9 million units worldwide.

    Product
    IntelliVue Patient Monitor MX850. Product Number: 866470.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0818-2026·2025-12-10

    8 in 1 STI Test Kit distributed without FDA premarket approval

    GET TESTED INTERNATIONAL AB recalled its 8 in 1 STI Test Kit after distributing 2043 units nationwide without FDA premarket approval or clearance. The unapproved device poses a risk of unreliable or inaccurate test results.

    Product
    8 in 1 STI Test Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0773-2026·2025-12-10

    Akkermansia diagnostic test distributed without FDA premarket clearance

    Akkermansia Test, manufactured by GET TESTED INTERNATIONAL AB, was distributed nationwide without required FDA premarket approval. All lot numbers are affected.

    Product
    Akkermansia Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0878-2026·2025-12-10

    MAMMOMAT Inspiration operator table recalled for improper bus-installation kit

    Siemens recalls the MAMMOMAT Inspiration operator table due to improper inclusion of a bus-installation kit. The table is designed for stationary operation only and cannot be safely used on buses.

    Product
    MAMMOMAT Inspiration;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0849-2026·2025-12-10

    IntelliVue MP2 patient monitors may fail to produce alarms

    Philips IntelliVue MP2 patient monitors may fail to produce alarms under certain conditions. The recall affects approximately 1.9 million units distributed worldwide to healthcare facilities.

    Product
    IntelliVue MP2. Product Number: M8102A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2026·2025-12-10

    Allergy Test Small recalled for lacking FDA premarket approval

    Allergy Test Small was distributed without FDA premarket approval or clearance. Consumers should discontinue use and consult their healthcare provider for proper allergy testing.

    Product
    Allergy test Small
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2026·2025-12-10

    SIBO Test Recalled for Distribution Without FDA Premarket Approval

    GET TESTED INTERNATIONAL AB is recalling 55 units of the SIBO Test distributed nationwide in the US because the product was marketed without FDA premarket approval or clearance.

    Product
    SIBO Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0854-2026·2025-12-10

    Philips IntelliVue MP50 patient monitors may fail to generate clinical alarms

    Philips IntelliVue MP50 patient monitors may fail to generate clinical alarms, prompting a recall. The affected monitoring equipment could fail to alert healthcare staff to patient conditions requiring intervention.

    Product
    IntelliVue MP50. Product Number: M8004A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0857-2026·2025-12-10

    Philips IntelliVue MP80 Patient Monitor Recall Due to Alarm Failure

    Philips is recalling the IntelliVue MP80 patient monitor because it may fail to generate alarms, potentially delaying critical patient care. Over 1.9 million units are affected worldwide.

    Product
    IntelliVue MP80. Product Number: M8008A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0872-2026·2025-12-10

    Olympus OER-Elite Medical Device Recall Requires Trained Service

    Aizu Olympus recalls the Olympus OER-Elite medical device affecting 6,578 units nationwide. Customers must follow maintenance schedules and use only trained personnel for service.

    Product
    Olympus OER-Elite
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0731-2026·2025-12-10

    D-Dimer Test Recalled for Distribution Without FDA Premarket Clearance

    GET TESTED INTERNATIONAL AB is recalling D-Dimer Test kits (1,218 units, all lots) distributed nationwide without FDA premarket approval. The unapproved test has not been reviewed by the FDA for safety and effectiveness.

    Product
    D-Dimer Test
    Category
    Medical Device
    Distribution
    Distributed nationwide