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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4426–4450 of 113838

  • 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
  • HighFDA (Drugs)·D-0295-2026·2026-01-28

    Icosapent ethyl capsules recalled as subpotent after capsule contents leaked

    Zydus Pharmaceuticals is recalling 22,896 bottles of Icosapent Ethyl capsules, 1 gram, because oxidation caused by leakage of the capsule contents has left them subpotent.

    Product
    Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
    Category
    Drug
    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 (Food)·H-0413-2026·2026-01-28

    Custom manifold kits recalled over inflation handles that may detach

    Merit Medical Systems is recalling 2,192 Custom Manifold Kits, REF K09-13203A, because the inflation device handle may detach from the syringe during a procedure.

    Product
    Gaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 24 oz (680g)) packaged in wax paper placed in clear bag and packed in cardboard carton. 12/ 24 oz per master case.
    Category
    Medical Device
    Distribution
    1 state
  • 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 (Food)·H-0411-2026·2026-01-28

    All human food products from one distributor recalled over rodent activity

    Gold Star Distribution is recalling all human food products distributed from the firm over potential exposure of rodents and rodent activity in the distribution center.

    Product
    All human food products distributed from the firm. Including but not limited to: snack foods, candy, gum, cooking oil, canned fruit and beans, honey, Dietary supplements, peanut butter, oatmeal, rice, dry peas and beans, ramen, cold cereal, hot sauce, lemon juice, crackers, can
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·26V049000·2026-01-28

    Toyota Prius models recalled for unexpected rear door opening risk

    Toyota is recalling certain 2023–2026 Prius and Prius Prime models because water may enter the rear door switch, causing an unlocked door to open unexpectedly while driving. This increases injury risk.

    Product
    TOYOTA — TOYOTA PRIUS PLUG-IN HYBRID, PRIUS PRIME, PRIUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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-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-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-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
  • ModerateFDA (Food)·H-0414-2026·2026-01-28

    Infusion pumps recalled over hard limit messages blocking piggyback flush programming

    ICU Medical is recalling Plum Duo Precision IV Pumps because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.

    Product
    Mini Gaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 12 oz (340g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 12 oz per master case.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1141-2026·2026-01-28

    Fetal and maternal monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 3,518 units of its Fetal & Maternal Monitor models F6, F9, F6 Express and F9 Express after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0412-2026·2026-01-28

    Classic Cuban loaf cake recalled over undeclared FD&C Yellow 5

    Catao Market is recalling 775 master cases of Gaceniga Authentic Cuban Loaf Cake Classic because the colour FD&C Yellow #5 was not declared on the label.

    Product
    Gacen¿iga Authentic Cuban Loaf Cake Classic (Net Wt. 24 oz (680g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 24 oz per master case.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1133-2026·2026-01-28

    Reusable hip trial components recalled over missing FDA premarket authorization

    MicroPort Orthopedics is recalling 91 units of the HIPTURN 36mm reusable femoral head trial because the product does not have FDA premarket authorization for US distribution.

    Product
    Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1149-2026·2026-01-28

    iX series patient monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 379 units of its Patient Monitor models iX10, iX12 and iX15 after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1136-2026·2026-01-28

    Laboratory tube sorters recalled over a lift that may drop unexpectedly

    Sysmex America is recalling 44 TS-10/TS-10H Tube Sorters because the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement.

    Product
    TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1146-2026·2026-01-28

    Elite V series patient monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 342 units of its Patient Monitor models elite V5, elite V6 and elite V8 after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Als
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1150-2026·2026-01-28

    Central monitoring systems recalled over potential cybersecurity issues flagged by FDA

    Edan Diagnostics is recalling 195 units of its MFM-CMS Central Monitoring System after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring info
    Category
    Medical Device
    Distribution
    Distributed nationwide