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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15676–15700 of 27762

  • HighFDA (Food)·F-0327-2024·2023-11-08

    Organic frozen waffles recalled due to undeclared peanuts

    Nature's Path Organic Dark Chocolate Chip Waffles are recalled because peanuts were not declared on the label, posing a risk to consumers with peanut allergies.

    Product
    Nature's Path Organic Dark Chocolate Chip Waffles, 7 oz., UPC 0 5844916701 3
    Category
    Food
    Distribution
    17 states
  • HighFDA (Drugs)·D-0079-2024·2023-11-08

    TUMS Antacid Recalled for Glass Mineral Wool Contamination

    GlaxoSmithKline is recalling TUMS antacid tablets in Lot KH5L due to glass mineral wool contamination. Affected consumers should stop use immediately.

    Product
    TUMS — TUMS (CALCIUM CARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0078-2024·2023-11-08

    TUMS Antacid Tablets Recalled for Glass Mineral Wool Contamination

    GlaxoSmithKline is recalling TUMS Antacid 1000 mg chewable tablets in Assorted Berries flavor due to glass mineral wool contamination found in some bottles. Product was distributed nationwide.

    Product
    TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0216-2024·2023-11-08

    Cepheid Xpert Xpress Strep A test kits may produce invalid results

    Cepheid is recalling 1,413 Xpert Xpress Strep A test kits due to a defect in the included pipettes. Defective pipettes may fail to dispense adequate sample volume, resulting in invalid test results or no test result.

    Product
    Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0214-2024·2023-11-08

    Unity Total Knee System Inserts May Be Mislabeled With Wrong Size

    Corin Ltd is recalling Unity Total Knee System inserts due to a labeling mix-up between batches 529803 and 532405, potentially affecting size 6 and size 7 designations.

    Product
    Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0211-2024·2023-11-08

    Cosmedent FlexiCup Polishing System Recalled for Crumbling Elastomer Cup

    Cosmedent is recalling the FlexiCup Composite Finishing & Polishing System due to reports that the elastomer cup material is crumbling. Approximately 7,400 packs distributed worldwide are affected.

    Product
    Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0084-2024·2023-11-08

    Liothyronine Sodium Tablets Recalled for Failed Impurity Specifications

    Sun Pharmaceutical is recalling approximately 2,304 bottles of Liothyronine Sodium Tablets, USP, 25 mcg (lot DNC2204A) due to failed impurity and degradation specifications. The affected medication was distributed nationwide.

    Product
    LIOTHYRONINE SODIUM — LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0215-2024·2023-11-08

    Cepheid Xpert Xpress Strep A test kits may produce invalid results

    Cepheid is recalling Xpert Xpress Strep A test kits because pipettes may fail to dispense adequate sample volume, potentially resulting in invalid or absent test results.

    Product
    Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0075-2024·2023-11-08

    TUMS Antacid Recalled for Glass Mineral Wool Contamination

    GlaxoSmithKline is recalling TUMS Antacid (1000mg Calcium Carbonate) due to the presence of glass mineral wool. The affected lot (HV6B) was distributed nationwide.

    Product
    TUMS — TUMS (CALCIUM CARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2024·2023-11-08

    AZUR CX 35 Peripheral Coil System Detachable Recalled for Unsealed Pouch Packaging

    MicroVention is recalling 14 units of the AZUR CX 35 Peripheral Coil System due to unsealed pouch packaging that could compromise device sterility. The affected units were distributed across eight states.

    Product
    AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0076-2024·2023-11-08

    TUMS Antacid Tablets Recalled for Glass Mineral Wool Contamination

    TUMS Antacid chewable tablets (Assorted Berries, 1000 mg, lot HR5W) are being recalled nationwide because some bottles contain glass mineral wool. Consumers should stop using affected bottles immediately.

    Product
    TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-02, UPC 3-0766-0746-50-8
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2024·2023-11-08

    Siemens X-Ray Systems Software Issue May Cause Patient Misdiagnosis

    Siemens Medical Solutions USA is recalling 367 mobile X-ray systems (186 Cios Flow and 181 Cios Spin) due to a software issue that may result in patient misdiagnosis and repeat radiation exposure. Affected units were distributed nationwide.

    Product
    ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2024·2023-11-08

    POC Analyzer Risk of Erroneous Creatinine Results During Cartridge Startup

    Nova Biomedical's Stat Profile Prime Plus POC analyzer may report inaccurate creatinine results during the first 2-4 hours after sensor cartridge installation. Standard quality control checks may not detect these errors.

    Product
    Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 63368 Stat Profile Prime Plus POC Analyzer (2) PN 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured P/N: 57400, 633
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0206-2024·2023-11-08

    Oncology Information System Document Values Not Visible in Read-Only Mode

    RayCare oncology information system versions 5B and 6A contain a software bug where document field values do not display when documents are opened in read-only mode outside the Documents workspace.

    Product
    RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care Product name (build number): (1)RayCare 5B SP1 (5.1.1.60246); (2)RayCare 5B
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0081-2024·2023-11-08

    Gynazole 1 Butoconazole Vaginal Cream Recalled for Formulation Error

    Padagis US LLC is recalling Gynazole 1 butoconazole nitrate vaginal cream nationwide due to a manufacturing error where hydrophilic colloidal silica was used instead of hydrophobic colloidal silica.

    Product
    GYNAZOLE 1 — GYNAZOLE 1 (BUTOCONAZOLE NITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0326-2024·2023-11-08

    Nature's Path Pumpkin Spice Waffles Recalled for Undeclared Peanut Allergen

    Nature's Path Organic Pumpkin Spice Waffles are being recalled due to undeclared peanut allergen. About 6,908 cases were distributed across 17 states.

    Product
    Nature's Path Organic Pumpkin Spice Waffles, 7 oz., UPC 0 5844959077 4
    Category
    Food
    Distribution
    17 states
  • HighFDA (Drugs)·D-0074-2024·2023-11-08

    FDA Recalls TUMS Antacid Tablets for Glass Mineral Wool Contamination

    GlaxoSmithKline is recalling TUMS Antacid tablets (Lot HA7G, expiration 8/31/2027) due to contamination with glass mineral wool. The product was distributed nationwide.

    Product
    TUMS — TUMS (CALCIUM CARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2024·2023-11-08

    RX Modena Clinical Chemistry Analyzer Recalled for Incorrect Rerun Results

    Randox Laboratories is recalling the RX Modena-IVD Clinical Chemistry Analyzer nationwide due to parameter re-run settings that may fail to function correctly when samples are outside the assay range, potentially resulting in incorrect test results.

    Product
    RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2024·2023-11-08

    RX Daytona Plus clinical chemistry analyzer may report incorrect test results

    The RX Daytona Plus clinical chemistry analyzer may report incorrect results when samples fall outside normal range and the automatic rerun feature malfunctions. Randox Laboratories is recalling 5 units distributed nationwide.

    Product
    RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2024·2023-11-08

    RX Daytona Plus Clinical Chemistry Analyzer Rerun Settings Malfunction

    Randox Laboratories is recalling the RX Daytona Plus (without ISE) IVD Clinical Chemistry Analyzer due to a flaw in rerun settings that may cause incorrect test result reporting.

    Product
    RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2024·2023-11-08

    Siemens Cios Alpha X-ray system software defect may cause patient misdiagnosis

    Siemens Cios Alpha (VA30) C-arm X-ray systems have a software issue that may not meet updated DIN and IEC standards. This defect could result in patient misdiagnosis or unnecessary repeat imaging.

    Product
    Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0202-2024·2023-11-08

    RX Monaco-IVD Clinical Chemistry Analyzer rerun feature may report incorrect results

    Randox Laboratories is recalling 13 RX Monaco-IVD Clinical Chemistry Analyzers with a rerun feature defect that may report incorrect test results when samples are outside normal assay range. Units were distributed nationwide including Puerto Rico.

    Product
    RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0213-2024·2023-11-08

    Orthopedic knee implant components mislabeled; size mix-up risk

    Corin Ltd recalled 3 Unity CR Femur knee implants due to labeling errors. Size 6 implants from batch 529803 may be labeled as size 7, and vice versa.

    Product
    Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Drugs)·D-0077-2024·2023-11-08

    TUMS Antacid 1000 mg Chewable Tablets Recalled for Glass Mineral Wool Contamination

    GlaxoSmithKline recalls TUMS Antacid 1000 mg Assorted Berries chewable tablets (lot HR6A) due to presence of glass mineral wool. The product was distributed nationwide.

    Product
    TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6
    Category
    Drug
    Distribution
    Distributed nationwide