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 the agency’s own highest classification or reported deaths or serious injuries, 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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13376–13400 of 114070

  • HighFDA (Devices)·Z-3216-2024·2024-10-02

    ACUSON Redwood Ultrasound Systems Recall for Software Unit Conversion Error

    Siemens ACUSON Redwood ultrasound systems may display measurements 10 times smaller than actual if operators change the software from factory defaults to milliliters per second or minute. This could lead to misdiagnosis and poor patient management.

    Product
    ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3288-2024·2024-10-02

    Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Detachment Risk

    Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 15 units distributed worldwide.

    Product
    AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3228-2024·2024-10-02

    Endovascular AAA Pack recalled for sterilization assurance failure

    American Contract Systems recalls 360 units of Endovascular AAA Pack due to inability to confirm sterilization requirements were met. An inoperable chart recorder prevented verification that environmental conditions during sterilization met required specifications.

    Product
    Endovascular AAA Pack, ESED52B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3256-2024·2024-10-02

    Biodesign Fistula Plug Implant Recalled for Premature Expiration

    Cook Biotech is recalling the Biodesign Fistula Plug implant because devices expire before their labeled expiration dates. Thirty-nine units distributed worldwide are affected.

    Product
    Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3218-2024·2024-10-02

    Karl Storz Hopkins Telescope 6 endoscope with unapproved reprocessing instructions

    Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.

    Product
    Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1823-2024·2024-10-02

    M&P Food Products Cheese Blintzes Recalled for Undeclared Wheat

    M&P Food Products Cheese Blintzes are recalled due to undeclared wheat in the product. Consumers with wheat allergies should not consume this frozen food.

    Product
    M&P Food Products Cheese Blintzes; Hand Made Russian Style; 6 Classic; NET WT. 14 OZ. (396g); KEEP FROZEN; INGREDIENTS: Flour, low fat milk, eggs, margarine, sugar, salt; FILLING INGREDIENTS: Farmer Cheese; Cheese Blintzes; UPC: 707163303251
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1829-2024·2024-10-02

    M&P Food Vareniki Products Recalled for Undeclared Wheat

    M&P Food Productions is recalling Potato & Mushroom Vareniki because the products contain undeclared wheat, which poses a risk to consumers with wheat allergies.

    Product
    Potato & Mushroom Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Potato, Mushroom, Fried Onion; UPC: 707163026174
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-3274-2024·2024-10-02

    WallFlex Esophageal Stent System Recalled Due to Catheter Tip Detachment Risk

    Boston Scientific recalls WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment affecting 77 units distributed worldwide.

    Product
    WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1831-2024·2024-10-02

    Marionberry Scones Recalled for Undeclared Soy Allergen

    Skagit River Bakery & Cafe is recalling marionberry scones distributed in Washington due to undeclared soy lecithin and soybean oil on labels. Consumers with soy allergies should not consume this product.

    Product
    Marionberry Scones, bulk packaged in cake boxes with parchment paper, unwrapped. Products are not individual labeled and are held in bulk for retail sale. Each location has a notebook with all the ingredients used in the scones.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-3245-2024·2024-10-02

    FDA Recalls Surgical Instrument Handle That May Break During Use

    The FDA is recalling LINK Universal Handles due to risk of material failure when first used. The surgical instrument may break during surgery, compromising patient safety.

    Product
    LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3263-2024·2024-10-02

    Ostomy barrier seals recalled for blistering and incorrect model labeling

    T.G. Eakin Limited is recalling blistered Cohesive seal ostomy barriers in Kentucky that are mislabeled with incorrect model numbers.

    Product
    eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-3205-2024·2024-10-02

    MRI diagnostic device screws may loosen and block tabletop

    Philips is recalling the Ingenia Elition X MRI device due to loose screws in the RF carrier assembly that could block the tabletop and delay diagnosis or cause patient anxiety.

    Product
    SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3258-2024·2024-10-02

    Biodesign Recto-Vaginal Fistula Plug expires before labeled expiration date

    Cook Biotech is recalling 3 units of Biodesign Recto-Vaginal Fistula Plug RVP-0.2 because the devices expire prior to the expiration date printed on the labeling.

    Product
    Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3192-2024·2024-10-02

    Biopsy instrument packaging holes compromise sterile barrier integrity

    Argon Medical Devices recalls BioPince Ultra and Tru-Core II biopsy instruments due to holes in packaging trays compromising the sterile barrier, which may allow microorganism introduction and infection risk.

    Product
    BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1827-2024·2024-10-02

    Sour Cherry Vareniki Recalled for Undeclared Wheat Allergen

    M & P Food Productions is recalling Sour Cherry Vareniki frozen dumplings due to undeclared wheat, a major allergen not listed on the label.

    Product
    Sour Cherry Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Sour Cherry, Sugar; UPC: 707163026150
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-3197-2024·2024-10-02

    MRI Device Ingenia Ambition S Screws May Loosen and Block Tabletop

    Assembly screws in Philips Ingenia Ambition S MRI systems may loosen and protrude, potentially blocking the patient tabletop and delaying diagnosis. Philips is recalling 64 affected units worldwide.

    Product
    Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782108 2) 781359 3) 782133
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3201-2024·2024-10-02

    Philips MR 5300 MRI System Recalled for Loose Assembly Screws

    Philips is recalling 68 MR 5300 MRI diagnostic systems worldwide because loose screws in the RF carrier assembly could block equipment movement and delay patient diagnosis.

    Product
    MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3213-2024·2024-10-02

    Cervical disc implant recalled due to foreign contamination during assembly

    Centinel Spine is recalling the Prodisc C SK cervical disc implant due to blue discoloration identified as foreign contamination on the inlay during assembly. The contamination was not fully evaluated in manufacturing validations.

    Product
    prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3290-2024·2024-10-02

    Esophageal stent systems recalled due to delivery catheter defect

    Boston Scientific has recalled AGILE and WallFlex esophageal stent systems due to potential delivery catheter tip detachment. This defect could occur during stent deployment and affect proper stent placement.

    Product
    AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3081-2024·2024-10-02

    GE Panda iRES infant warmer electrical safety testing incomplete

    GE Panda iRES infant warmers may have incomplete electrical safety testing that could cause leakage current to exceed safe limits. The company is recalling 137 units distributed in the US and internationally.

    Product
    GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M1112198-01047148; 4) M1112198-01047271; 5) M1112198-01048731; 6) M1112198-01048740; 7) M1112198-01052386; 8) M1112198-01054697; 9) M1112198-01068942; 10)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1830-2024·2024-10-02

    Farmer Cheese Vareniki recalled for undeclared wheat and milk allergens

    M&P Food Productions is recalling Farmer Cheese Vareniki due to undeclared wheat and milk allergens. The frozen product was distributed across seven states from August 2023 to August 2024.

    Product
    Farmer Cheese Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Farmer Cheese; UPC: 707163026181
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-3275-2024·2024-10-02

    Boston Scientific Esophageal Stents Recalled for Catheter Tip Detachment Risk

    Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The recall affects 231 units distributed worldwide.

    Product
    WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1826-2024·2024-10-02

    M&P Delicacies Pirozhki Pies Recalled for Undeclared Wheat and Milk

    M&P Food Productions recalls frozen Pirozhki pies distributed across multiple states due to undeclared wheat and milk in the product. Consumers with wheat or milk allergies should not consume these products.

    Product
    M&P Delicacies PIROZHKI (PIES) with CABBAGE; INGREDIENTS: Flour, eggs, butter, vegetable oil, dry yeast, sugar, salt; Filling: cabbage, carrot, sauerkraut, onion, salt, pepper; 1 SERVING READY TO EAT; KEEP FROZEN
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-3299-2024·2024-10-02

    Arrow Arterial Kits Recalled Due to Open Packaging Seals

    Arrow International recalls over 14,000 arterial kits due to reports of open packaging seals. The recall affects multiple models distributed nationwide.

    Product
    Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1825-2024·2024-10-02

    M&P Delicacies Pirozhki Frozen Pies Recalled for Undeclared Wheat and Milk

    M&P Delicacies frozen pirozhki pies contain undeclared wheat and milk allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    M&P Delicacies PIROZHKI (PIES) with POTATOES; INGREDIENTS: Flour, eggs, butter, vegetable oil, dry yeast, sugar, salt; Filling: Potatoe, onion, salt, pepper; 1 SERVING READY TO EAT; KEEP FROZEN
    Category
    Food
    Distribution
    7 states