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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1926–1950 of 39824

  • CriticalFDA (Devices)·Z-1014-2026·2026-01-28

    Full electric low homecare beds recalled over hand pendants that overheat

    Medline is recalling 22,565 units of the Full Electric Low Basic Homecare Bed because the hand control pendant and its cords may overheat and, in rare instances, pose a risk of fire.

    Product
    MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1125-2026·2026-01-28

    Waste management vascular trays recalled over inflation handles that may detach

    Merit Medical Systems is recalling 864 units of its Custom Waste Management Kit Vascular Tray because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1108-2026·2026-01-28

    RayStation 2024A treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 15.2.0 and 15.1.3 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1107-2026·2026-01-28

    Blood transfusion filters recalled over unconfirmed sterility assurance before release

    GVS TM is recalling 2,720 SQ40S Blood Transfusion Filters from one lot because they were released for distribution before the required quality control release process was completed.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1103-2026·2026-01-28

    RayStation 11A treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 11.0.0, 11.0.1, 11.0.3 and 11.0.4 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1135-2026·2026-01-28

    LDL cholesterol assays recalled over triglyceride interference causing biased results

    Beckman Coulter is recalling 34,451 units of the LDL Cholesterol OSR6x96 assay because triglyceride interference may cause a positive bias of up to 28.8% in low LDL cholesterol samples.

    Product
    The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a c
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1123-2026·2026-01-28

    basixCOMPAK inflation devices recalled over handles that may detach

    Merit Medical Systems is recalling 4,163,123 units of the Merit Medical Inflation Device basixCOMPAK because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2026·2026-01-28

    RayStation 2023B and 2024A recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 14.0.0, 15.0.0 and 15.1.3 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1145-2026·2026-01-28

    Endoluminal vision probe bags recalled over compromised sterile pouch seals

    Intuitive Surgical is recalling 110,580 Ion Vision Probe Bags because the probe bags may have a compromised or incomplete sterile pouch seal.

    Product
    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2026·2026-01-28

    Custom inflation kits recalled over inflation handles that may detach

    Merit Medical Systems is recalling 18,897 units of its Custom Inflation Kit because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2026·2026-01-28

    Custom procedure kits recalled over inflation handles that may detach

    Merit Medical Systems is recalling its Custom Procedure Kit because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1110-2026·2026-01-28

    RayStation v2025 treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 17.0.0 and 17.0.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1129-2026·2026-01-28

    Angioplasty packs recalled over inflation handles that may detach

    Merit Medical Systems is recalling 328,000 units of the Allwell Angioplasty Pack because the inflation device handle may detach from the syringe during a procedure.

    Product
    Allwell Angioplasty Pack REF: IS-30-B1/B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2026·2026-01-28

    Angiographic inflation devices recalled over handles that may detach

    Merit Medical Systems is recalling 173,645 units of the Allwell Inflation Device because the inflation device handle may detach from the syringe during a procedure.

    Product
    Allwell Inflation Device, for angiographic use REF: IS-30-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1113-2026·2026-01-28

    Azurion imaging systems recalled over two software issues affecting imaging

    Philips is recalling 228 Azurion systems on software version R3.1 over two software issues that may result in loss of imaging, loss of motorized movement, incorrect image content or loss of data.

    Product
    Philips Azurion system; Software Version Number: R3.1;
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1109-2026·2026-01-28

    RayStation 2024B treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan model 16.0.0 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1121-2026·2026-01-28

    SIGMA Spectrum infusion pumps recalled over defective grease on the gears

    Baxter Healthcare is recalling 585 SIGMA Spectrum Infusion Pumps because defective grease on the cam and motor gears could lead to over-infusion or a free-flow situation.

    Product
    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2026·2026-01-28

    RayStation 11B treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 12.0.0, 12.1.0, 12.0.3, 12.0.4 and 12.3.0 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1112-2026·2026-01-28

    PET scanners recalled over a streaking artifact in clinical images

    GE HealthCare is recalling 364 Omni Legend PET systems because an intermittent issue can produce a streaking artifact in PET clinical scan images.

    Product
    GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1105-2026·2026-01-28

    RayStation 12A treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 13.0.0.1547, 13.1.0.144 and 13.1.1.89 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1111-2026·2026-01-28

    Needle free access connectors recalled over silicone seals that may tear

    ICU Medical is recalling 14,684,607 Tego Connectors because the silicone seal may bulge, separate from the body or tear, which can cause fluid leaks, occluded flow or air infused into the body.

    Product
    Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1157-2026·2026-01-28

    RayStation 10B SP1 recalled over radiation dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan model 10.1.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    SQ40S Blood Transfusion Filter
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1143-2026·2026-01-28

    iM3 vital signs monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 11,987 units of its iM3 Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1138-2026·2026-01-28

    iM20 patient monitors recalled over potential cybersecurity issues flagged by FDA

    Edan Diagnostics is recalling 377 units of its iM20 Patient Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. The low base variant includes smaller casters and lower base frame so that th
    Category
    Medical Device
    Distribution
    Distributed nationwide