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.

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2201–2225 of 39987

  • HighFDA (Devices)·Z-0725-2026·2025-12-10

    Fecal immunochemical tests recalled over the potential for false negative results

    Enterix is recalling 201,426 InSure ONE Fecal Immunochemical Test kits after the test failed sensitivity testing with one test card lot, which may result in false negative results.

    Product
    InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2026·2025-12-10

    IntelliVue MP90 monitors recalled because an alarm may not sound

    Philips North America is recalling the IntelliVue MP90 over a potential issue where the monitors did not alarm.

    Product
    IntelliVue MP90. Product Number: M8010A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0880-2026·2025-12-10

    Clotting time test cuvettes recalled over a sharp-edged foreign object

    Accriva Diagnostics is recalling 20,250 Hemochron Activated Clotting Time Low-Range test cuvettes because a foreign object with sharp edges may pose a risk of injury if not detected before handling.

    Product
    Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0884-2026·2025-12-10

    DNA sequencing reagent kits recalled over flow cell gasket leaks

    Illumina is recalling 11,916 NextSeq 550Dx reagent kits because flow cell gaskets have a quality issue that may cause leaks during runs, including possible toxic substance exposure to the user.

    Product
    Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 2002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0859-2026·2025-12-10

    IntelliVue X2 measurement servers recalled over a potential failure to alarm

    Philips North America is recalling the IntelliVue Multi Measurement Server X2 over a potential issue where the monitors did not alarm.

    Product
    IntelliVue Multi Measurement Server X2. Product Number: M3002A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2026·2025-12-10

    Fibula nails recalled over out of specification thread depths on the implant

    Paragon 28 is recalling 20 Phantom Fibula Nails because out of specification thread depths may prevent the implant from mating with its mounting bolt, potentially requiring surgery to be aborted.

    Product
    Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2026·2025-12-10

    IntelliVue MX600 patient monitors recalled because an alarm may not sound

    Philips North America is recalling the IntelliVue Patient Monitor MX600 over a potential issue where the monitors did not alarm.

    Product
    IntelliVue Patient Monitor MX600. Product Number: 865242.
    Category
    Medical Device
    Distribution
    Distributed nationwide