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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15051–15075 of 27762

  • HighFDA (Devices)·Z-0544-2024·2023-12-20

    FDA Recalls VITROS 4600 Chemistry System for Software-Related Freezes

    Ortho-Clinical Diagnostics is recalling 51 units of the VITROS 4600 Chemistry System due to software defects causing system freezes and disconnections that could delay critical test result reporting.

    Product
    VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0553-2024·2023-12-20

    X-ray system overhead suspension components may fall due to incorrect bolt torque

    GE HealthCare Definium Tempo and Tempo Pro X-ray systems may have been assembled with incorrect bolt torque, creating a risk that Overhead Tube Suspension components could fall.

    Product
    The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0529-2024·2023-12-20

    Medline PVP Solution Recalled Due to Mislabeled Sterility

    Medline PVP Solution (REF DYNDA1858) is being recalled because it is labeled as sterile but contains non-sterile contents. 1,950 units are affected.

    Product
    PVP SOLUTION SING STRL, REF DYNDA1858
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0148-2024·2023-12-20

    Penicillamine Tablets Recalled Due to Failed Dissolution Specifications

    Lupin Pharmaceuticals is recalling Penicillamine Tablets USP 250 mg (Lot M200498) due to failed dissolution specifications. The affected tablets may not dissolve as intended, potentially affecting drug performance.

    Product
    PENICILLAMINE — PENICILLAMINE (PENICILLAMINE)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0545-2024·2023-12-20

    Laboratory Diagnostic System Software Defects Cause System Freezes and Result Delays

    The VITROS 5600 laboratory analyzer is being recalled due to software issues causing screen freezes and printer disconnections that delay test result reporting, potentially affecting patient care.

    Product
    VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2024·2023-12-20

    Sterile Prep Stick Recall: Non-Sterile Contents Despite Sterile Labeling

    Medline Industries is recalling sterile prep sticks (REF DYNDA1134) labeled as sterile that contain non-sterile solution, posing infection risk in medical procedures.

    Product
    STERILE STERILE PREP STICK, REF DYNDA1134
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2024·2023-12-20

    FDA Recalls 4Kscore Prostate Cancer Diagnostic Test Over Model Concerns

    BioReference Health is recalling the 4Kscore Test, a prostate cancer risk diagnostic test used nationwide. The recall follows mathematical modeling performed on over 3,000 specimens regarding digital rectal exam (DRE) information requirements.

    Product
    The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0510-2024·2023-12-20

    Wilcox Premium Coffee Recalled Due to Listeria Contamination

    Wilcox Premium Coffee products with Best By dates from September 14 to November 14, 2024, may be contaminated with Listeria monocytogenes. Products were distributed in Vermont, New Hampshire, Massachusetts, and New York.

    Product
    Wilcox Premium Coffee; 4 oz Cup; UPC 04372600403; Wilcox Premium Coffee in 1.5QT, Quart, Pint, 3 Gallon, and 1 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0570-2024·2023-12-20

    Frozen Tilapia and Tuna Products Recalled Due to Temperature Abuse

    Ben E Keith Foods is recalling 1,721 cases of frozen tilapia fillets and tuna loin products due to temperature abuse during transport. Products were distributed to food service operations.

    Product
    TILAPIA FILLET 5-7 OZ BLSL, TUNA LOIN AHI 3-5LB
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0551-2024·2023-12-20

    Medical imaging software incorrectly displays patient studies to wrong patients

    Change Healthcare's Stratus Imaging PACS software can incorrectly associate patient imaging studies with the wrong patients. Approximately 454 affected units have been distributed nationwide.

    Product
    Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0522-2024·2023-12-20

    SynchroMed Model A10 Infusion Pump Software Display Error

    Medtronic is recalling 2,543 SynchroMed Model A10 infusion pumps with software version 1.1.300 due to missing decimal separators on parameter display screens. The omission could lead to misinterpretation of dosing parameters.

    Product
    Medtronic SynchroMed, Model A10
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0660-2024·2023-12-20

    Gaw's Ham & Cheddar Bagels recalled due to undeclared sesame allergen

    Gaws Gourmet Foods is recalling Gaw's Ham & Cheddar Bagels due to undeclared sesame. The product label does not list sesame, posing a risk to consumers with sesame allergies.

    Product
    Gaw's Ham & Cheddar Bagel 6oz, Foam Tray with Clear Plastic Wrap package, UPC:1725600500
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0524-2024·2023-12-20

    Medical Device Recall: PHYSICA HPS Tibial Liner Incorrect Labeling

    Limacorporate is recalling 33 PHYSICA HPS Tibial Liner units distributed in the U.S. due to incorrect product labeling. No adverse events have been reported.

    Product
    PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0523-2024·2023-12-20

    Collision Sensor Malfunction in Siemens ARTIS Icono Fluoroscopic X-Ray System

    The ARTIS icono fluoroscopic x-ray system may falsely detect collisions for up to 30 minutes after startup, requiring manual override with reduced safety protection and limiting diagnostic use.

    Product
    ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0658-2024·2023-12-20

    Gaw's Italian Sub Recalled for Undeclared Sesame Allergen

    Gaws Gourmet Foods is recalling Gaw's Classic Italian sub due to undeclared sesame. The recall affects 699 units distributed in Michigan; consumers who are allergic to sesame should not consume the product.

    Product
    Gaw's Classic Italian sub 8oz, Foam Tray with Clear Plastic Wrap package, UPC:1725600920
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0558-2024·2023-12-20

    Ice cream recalled for potential Listeria contamination in 3-gallon containers

    Wilcox Premium Salted Caramel Turtle ice cream (3-gallon) may be contaminated with Listeria monocytogenes. Affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York with best-by dates September 14–November 14, 2024.

    Product
    Wilcox Premium Salted Caramel Turtle in 3 Gallon size
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0574-2024·2023-12-20

    Frozen and refrigerated foods recalled due to temperature abuse

    Ben E Keith Foods has recalled 1721 cases of frozen and refrigerated foods that were temperature abused during storage and transit. The temperature-compromised products were distributed to food service operations.

    Product
    LEMON CHOICE MINI PK 34-44 CT; STRAWBERRY SLICED 4-1
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0552-2024·2023-12-20

    GE Definium Tempo X-Ray System Bolts May Loosen and Fall

    Incorrect bolt torque on GE Definium Tempo X-ray systems may cause the overhead tube suspension assembly to fall. No injuries have been reported, but GE recommends immediate inspection of affected systems.

    Product
    The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·24056·2023-12-14

    Polaris RZR 200 Youth Off-Road Vehicles Recalled for Steering Lock-Up Hazard

    Polaris is recalling about 19,000 Model Year 2021-2024 RZR 200 youth off-road vehicles because the steering system can lock up during use, posing a crash hazard and risk of serious injury to children.

    Product
    Model Year 2021-2024 RZR 200 Youth ROVs
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24735·2023-12-14

    Can-Am Side-by-Side Vehicles Recalled for Clutch Failure Risk

    BRP is recalling about 14,555 Model Year 2022 and 2023 Can-Am Commander, Defender, and Maverick Trail side-by-side vehicles because the operator's guide contains incorrect maintenance intervals for the clutch, which can lead to clutch failure and fragment ejection, posing a risk of serious injury.

    Product
    Can-Am® Commander series, Defender series, Maverick Trail series equipped with an HD7 or 700 engines side-by-side vehicles (Model Year 2022 and 2023)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24736·2023-12-14

    Kubota RTV-XG850 Utility Vehicles Recalled for Steering Hazards

    Kubota is recalling about 3,170 RTV-XG850 Sidekick utility vehicles sold between March 2023 and September 2023 due to improper steering shaft assembly that could cause loss of control and crash hazards.

    Product
    Utility Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24734·2023-12-14

    Collegiate English Horse-Riding Saddles Recalled for Fall Injury Risk

    WeatherBeeta USA is recalling about 2,300 Collegiate English horse-riding saddles because the rivet or stirrup bar can break, causing the rider to fall. One fall injury has been reported.

    Product
    Collegiate English Horse-Riding Saddles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24055·2023-12-14

    Polaris Ranger XP Kinetic Off-Road Vehicles Recalled Due to Crash Hazard

    Polaris is recalling Model Year 2023-2024 Ranger XP Kinetic recreational off-road vehicles because pressing the brake and throttle pedals together can deactivate the throttle, creating a crash hazard when the brake is released.

    Product
    Model Year 2023-2024 Ranger XP Kinetic Recreational Off-Road Vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24060·2023-12-14

    Room & Board Griffin Duo Bunk Beds Recall Due to Collapse Risk

    Room & Board is recalling about 500 Griffin Duo Bunk Beds sold from May 2013 through May 2017 because some units lack properly installed set screws in the side rail brackets, creating a risk of collapse and fall injuries. Two collapse incidents have been reported with no injuries.

    Product
    Room & Board Griffin Duo Bunk Beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24051·2023-12-14

    Empower Brands Recalls PowerXL Dual-Basket Air Fryers Due to Burn Hazard

    Empower Brands is recalling about 319,000 PowerXL DUAF-10 and DUAF-005 Vortex Dual-Basket Air Fryers because the plastic U-Channel connector can break during use, posing a burn hazard. The firm has received 41 reports of breakage, including three burn injuries.

    Product
    PowerXL™ DUAF-10 and DUAF-005 Vortex Dual-Basket Air Fryers
    Category
    Consumer Product
    Distribution
    Distributed nationwide