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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24901–24925 of 26084

  • HighFDA (Devices)·Z-2282-2021·2021-08-18

    Edwards PediaSat Oximetry Catheter Set recalled for potential internal leaks

    Edwards Lifesciences is recalling its PediaSat Oximetry Catheter Set due to potential for internal leaks within the device.

    Product
    Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197556
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Food)·F-0858-2021·2021-08-18

    Molly and Me Pecans Recalled for Undeclared Soy

    Molly and Me Pecans praline pecans are being recalled because they contain undeclared soy, which poses a risk to consumers with soy allergies.

    Product
    MOLLY & ME PECANS all natural PRALINE PECANS, 4 oz., 7 oz., and 12 oz packages, INGREDIENTS: Pecans, Brown Sugar, Evaporated Milk, Margarine, Light Corn syrup, Artificial Vanilla Flavor. ALLERGEN INFORMATION CONTAINS MILK, PECANS & MAY CONTAIN OTHER TREE NUTS. PRODUCED & DISTRIBU
    Category
    Food
    Distribution
    28 states
  • HighCPSC·21183·2021-08-18

    Marin Mountain Bicycles Recalled for Fall and Crash Hazards

    Marin Mountain Bikes is recalling approximately 2,100 Model Year 2021 mountain bicycles because the bottom bracket can break during use, causing loss of control and fall hazards. The firm has received nine reports of broken bottom brackets but no injuries have been reported.

    Product
    Mountain Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2238-2021·2021-08-18

    Prelude SNAP cardiac introducer sheath potentially mislabeled with wrong size

    Merit Medical Systems is recalling Prelude SNAP Splittable Sheath Introducers (10F size) because 7F sheaths may have been packaged with 10F labels. This error affects 760 units in lot I2067768.

    Product
    Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-2279-2021·2021-08-18

    Edwards PediaSat Oximetry Catheter Kit Recalled for Internal Leak Risk

    Edwards Lifesciences recalls PediaSat Oximetry Catheter Kits (REF: XT3515SP) due to potential for internal leaks that could affect oxygen saturation monitoring.

    Product
    Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197532
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2245-2021·2021-08-18

    FDA Recalls Blood Culture Identification Panel for False Negative Results

    BioFire Diagnostics is recalling 29 FilmArray Blood Culture Identification Panel kits distributed nationwide due to false negative test results caused by a pouch manufacturing error.

    Product
    FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2021·2021-08-18

    Arcos Hip Implant Component Recalled for Potential Device Failure

    Biomet recalled 10 units of Arcos hip implant components (lot 934870) nationwide due to potential inner taper corrosion and device failure that may require surgical intervention.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2228-2021·2021-08-18

    Medtronic StimLoc Burr Hole Cover Recalled for Excess Nylon Flash on Clip

    Medtronic is recalling StimLoc Burr Hole Cover neurosurgical devices and related components due to excess nylon flash on the clip. The defect could affect device function during implantation or use.

    Product
    Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Food)·F-0850-2021·2021-08-18

    5000 Years Foods Julrado Whole Cabbage Kimchi Recall for Listeria

    5000 Years Foods is recalling Julrado Whole Cabbage Kimchi in multiple sizes due to potential Listeria monocytogenes contamination. The product was distributed in Illinois and potentially nationwide through retail distributors.

    Product
    5000 Years Foods JULRADO WHOLE CABBAGE KIMCHI in 5GAL plastic tubs, and 128 oz and 64 oz glass jars
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2021·2021-08-18

    ACCESS SARS-CoV-2 Antigen Extraction Solution recalled for potential false positive results

    Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen Extraction Solution nationwide because the assay test may generate false positive results, leading to incorrect diagnosis.

    Product
    ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21182·2021-08-18

    B-Air VP-33 Blower Fans Recalled Due to Fire Hazard

    Intertex is recalling about 29,500 B-Air VP-33 blower fans because the capacitor can overheat and pose a fire hazard. The firm has received five reports of fire-related property damage totaling about $75,000, though no injuries have been reported.

    Product
    B-Air VP-33 Blower Fans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2272-2021·2021-08-18

    Hip Implant Component Recalled Due to Potential Fretting Corrosion and Device Failure

    Biomet is recalling hip replacement components that could develop fretting corrosion and fail inside the body, potentially requiring revision surgery.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0854-2021·2021-08-18

    5000 Years Foods Kimchi Recalled for Listeria Contamination Risk

    5000 Years Foods is recalling NO MSG JULRADO WHOLE CABBAGE KIMCHI in 128 oz and 64 oz glass jars due to potential Listeria monocytogenes contamination. The affected product was distributed through Illinois and reached customers nationwide.

    Product
    5000 Years Foods NO MSG JULRADO WHOLE CABBAGE KIMCHI in 128 oz and 64 oz glass jars
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2247-2021·2021-08-18

    Jamshidi Bone Marrow Biopsy Needles Recalled for Packaging Seal Defects

    Bard Peripheral Vascular Inc. is recalling multiple models of Jamshidi bone marrow biopsy needles due to incomplete or open packaging seals that may compromise sterility. No illnesses or injuries have been reported.

    Product
    TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2021·2021-08-18

    Codman Raney Scalp Clips recalled for compromised sterile barrier packaging

    Integra LifeSciences is recalling Codman Raney Scalp Clips (lot numbers W2102045, W2102046, W2102048, W2102049) due to wrinkles in the packaging that may compromise the sterile barrier.

    Product
    CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2021·2021-08-18

    Cordis SABER PTA Balloon Catheter Recalled for Foreign Material Contamination

    Cordis Corporation is recalling the SABER PTA Balloon Dilation Catheter due to potential contamination with foreign material from manufacturing. The contamination may transfer from the protective sheath to the balloon itself.

    Product
    Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2021·2021-08-18

    FDA Recalls Biomet Hip Implant for Potential Fretting Corrosion

    Biomet is recalling its Arcos Modular Revision Hip System Standard Cone Prox Body due to risk of fretting corrosion and device failure in the inner taper. Affected patients should consult their surgeon.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2261-2021·2021-08-18

    Arcos Modular Revision Hip System Cone Bodies Recalled for Device Failure Risk

    Biomet, Inc. is recalling 21 units of Arcos Modular Revision Hip System Standard Cone Prox Bodies due to risk of fretting corrosion and device failure that may require surgical intervention.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0857-2021·2021-08-18

    5000 Years Foods Baby Napa Kimchi Recall for Listeria Contamination

    5000 Years Foods is recalling Baby Napa Kimchi in 128 oz, 64 oz, and 32 oz glass jars due to potential contamination with Listeria monocytogenes. The product was distributed in Illinois and potentially nationwide through retail distributors.

    Product
    5000 Years Foods BABY NAPA KIMCHI in 128 oz, 64 oz, and 32 oz glass jars
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2280-2021·2021-08-18

    Edwards PediaSat Oximetry Catheter Kits Recalled for Potential Internal Leaks

    Edwards Lifesciences is recalling PediaSat Oximetry Catheter Kits due to potential internal leaks within the devices. The recall involves 218 units distributed across multiple U.S. states and internationally.

    Product
    Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2273-2021·2021-08-18

    Biomet Hip Implant System Recalled Due to Potential Fretting Corrosion

    Biomet is recalling the Arcos Modular Revision Hip System component due to potential inner taper fretting corrosion that could lead to device failure requiring surgery. No injuries have been reported.

    Product
    Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0856-2021·2021-08-18

    5000 Years Foods White Whole Kimchi Recall Due to Listeria Risk

    5000 Years Foods is recalling White Whole Kimchi in 32 oz, 64 oz, and 128 oz glass jars due to potential Listeria monocytogenes contamination. The affected product was distributed through Illinois to retail locations potentially nationwide.

    Product
    5000 Years Foods WHITE WHOLE KIMCHI in 128 oz, 64 oz, and 32 oz glass jars
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2021·2021-08-18

    Spectrum Medical Quantum Standard Heat Exchanger Sterilization Defect Recall

    QURA S.R.L. is recalling 1088 units of Spectrum Medical Quantum Standard heat exchangers that may not be adequately sterilized. The devices also lack required 510(k) clearance for US distribution.

    Product
    Spectrum Medical Quantum Standard heat exchanger
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2207-2021·2021-08-18

    Stryker Prime Fifth Wheel Stretcher distributed to residential customers instead of healthcare facilities

    A medical stretcher designed for healthcare professionals was distributed to residential customers. The device labeling is appropriate for healthcare settings, but home users may not understand or follow the professional-use instructions.

    Product
    Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2220-2021·2021-08-18

    Stretcher Chair Model 5050 Incorrectly Distributed to Residential Customers

    Stryker's Model 5050 stretcher chair was distributed to residential customers despite being designed for healthcare professionals. Home users may not understand instructions intended for trained medical staff, creating a risk of misuse.

    Product
    Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000
    Category
    Medical Device
    Distribution
    Distributed nationwide