The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

7776–7800 of 26961

  • HighFDA (Food)·F-0344-2025·2025-01-08

    Watermelon Halo Products Recalled for Potential Listeria Contamination

    King Kullen and Gracie's Kitchen brand Watermelon Halo products are being recalled due to potential Listeria monocytogenes contamination. The products were distributed in Connecticut and New York with sell-by dates from November 11 through November 21, 2024.

    Product
    a.) King Kullen brand Watermelon Halo; UPC: 85316-10392; 26 oz plastic container b.) Gracie's Kitchen brand Watermelon Halo; UPC: 85316-10392; 26 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0366-2025·2025-01-08

    Minnesota Milk Bank Donor Human Milk Recalled for Undetermined Foreign Material

    Minnesota Milk Bank for Babies is recalling 136 bottles of pasteurized donor human milk due to potential contamination with undetermined foreign material. The affected batch (002237-1) expires 01/01/2025.

    Product
    MN Milk Bank for Babies Pasteurize Donor Human Milk. Volume: 4 fl. oz. / 120 ml. Milk Type: 20 kcal/oz. 1.0 g/dL Total Protein. MN Milk Bank for Babies, Roseville, MN 55113
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0322-2025·2025-01-08

    King Kullen and Wild by Nature vegetable platters recalled for Listeria

    Gracie's Kitchens Inc. is recalling King Kullen and Wild by Nature brand vegetable platters (44 oz) distributed in Connecticut and New York due to potential Listeria monocytogenes contamination. Affected products have sell-by dates from November 14-24, 2024.

    Product
    a.) King Kullen brand Vegetable Platter; UPC 85316-10005; 44oz plastic container b.) Wild by Nature brand Vegetable Platter; UPC 85316-10005; 44 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0320-2025·2025-01-08

    Chocolate Raspberry Bakery Products Recalled for Undeclared Allergens and Color Additives

    Lithuanian Bakery, Inc. is recalling Chocolate Raspberry baked goods in three sizes due to undeclared milk, soy, peanut, wheat, sulfites, and color dyes. Consumers with allergies should not consume these products.

    Product
    Chocolate Raspberry: Three sizes, 1. Small, Net Wt 1.25 lbs. (sub ingredients contain, yellow #5 and #6, and red #40 not declared on final product label) 2. Medium, Net Wt 2.75 lbs. (sub ingredients contain milk, yellow #5 and #6, and red #40 not declared on final product labe
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0351-2025·2025-01-08

    Gracie's Kitchen Broccoli & Cauliflower Florets Recalled for Listeria

    Gracie's Kitchen brand Broccoli & Cauliflower Florets (12 oz foam trays) are being recalled due to potential Listeria monocytogenes contamination. The recalled products were distributed in Connecticut and New York.

    Product
    a.) Gracie's Kitchen brand Broccoli & Cauliflower Florets; UPC: 85316-1009; 12 oz foam tray
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0798-2025·2025-01-08

    Ophthalmic Surgical Device Recalled for Potential Sterile Barrier Compromise

    Carwild Corporation is recalling Ivalon Eye Wick 20cm surgical devices due to package seals that are out of specification and cannot guarantee sterile barrier integrity for the life of the product.

    Product
    Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-0340-2025·2025-01-08

    Gracie's Kitchens Mango Berry Products Recalled for Listeria Risk

    Mango Berry smoothies sold under King Kullen, Wild By Nature, and Gracie's Kitchen brands may be contaminated with Listeria monocytogenes. Affected products have Sell By dates between 11/11/24 and 11/21/24.

    Product
    a.) King Kullen brand Mango Berry; UPC: 85316-10378; 12 oz plastic container b.) Wild By Nature brand Mango Berry; UPC: 85316-10378; 12 oz plastic container c.) Gracie's Kitchen brand Mango Berry; UPC: 85316-10325; 12 oz plastic container d.) Gracie's Kitchen brand Mango Berry Cu
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0775-2025·2025-01-08

    Baxter SIGMA Spectrum Infusion Pump Recalled for Incomplete Post-Repair Testing

    Baxter is recalling SIGMA Spectrum Infusion Pump (Version 6) units that were released after repair without complete flow testing. The incomplete testing poses a risk of improper device operation.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0327-2025·2025-01-08

    Stuffed Artichokes Recalled Due to Possible Listeria Contamination

    King Kullen and Gracie's Kitchen brand stuffed artichokes have been recalled because they may be contaminated with Listeria monocytogenes. Consumers should not eat these products.

    Product
    a.) King Kullen brand Stuffed Artichokes; UPC: 85316-10061; 16 oz foam tray b.) Gracie's Kitchen brand Stuffed Artichokes; UPC: 85316-10055; 16 oz foam tray
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0783-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled for Non-Sterile Components

    Medline is recalling 943 custom surgical kits containing non-sterile Codman Surgical Patties and Strips that may be contaminated with endotoxin.

    Product
    Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; 4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0773-2025·2025-01-08

    Medtronic Implantable Drug Pumps Recalled for Software Defects

    Medtronic has recalled 566 SynchroMed II and III implantable drug infusion pumps due to software issues in the controlling application. No injuries or illnesses have been reported.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0328-2025·2025-01-08

    Diced Celery Products Recalled Due to Potential Listeria Contamination

    Gracie's Kitchens Inc. is recalling multiple brands of diced celery sold in Connecticut and New York due to potential Listeria monocytogenes contamination.

    Product
    a.) King Kullen brand Diced Celery; UPC: 85316-10083; 12 oz plastic container b.) Wild By Nature brand Diced Celery; UPC: 85316-10083; 12 oz plastic container c.) Gracie's Kitchen brand Diced Celery: UPC: 85316-10020; 10 oz plastic container d.) Gracie's Kitchen brand Diced Celer
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0354-2025·2025-01-08

    Gracie's Kitchen Diced Carrots recalled for potential Listeria monocytogenes contamination

    Gracie's Kitchen brand Diced Carrots may be contaminated with Listeria monocytogenes. The recall affects 3,681 cases distributed in Connecticut and New York with sell-by dates between November 12-22, 2024.

    Product
    a.) Gracie's Kitchen brand Diced Carrots; UPC: 85316-10019; 10 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0792-2025·2025-01-08

    Medline Medical Procedure Kits Recalled for Non-Sterile Component Contamination

    Medline Industries is recalling 2,664 custom medical procedure kits containing non-sterile surgical components with potential endotoxin contamination. The affected kits were distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, REF DYNJ906448A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2025·2025-01-08

    Medline custom surgical procedure kits recalled for non-sterile components

    Medline is recalling 182 custom surgical procedure kits containing non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. The kits were distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR CERVICAL-CORPECTOMY, REF DYNJ904827.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0333-2025·2025-01-08

    Brussel Sprout Products Recalled for Potential Listeria Contamination

    Gracie's Kitchens Inc. is recalling brussel sprout products sold under King Kullen, Wild by Nature, and Gracie's Kitchen brands due to potential Listeria monocytogenes contamination. Affected products were distributed in Connecticut and New York.

    Product
    a.) King Kullen brand Brussel Sprout Halves; UPC: 85316-10097; 12 oz plastic container b.) King Kullen brand Brussel Sprouts Shredded; UPC: 85316-10098; 12 oz plastic container c.) Wild by Nature brand Brussel Sprout Halves; UPC: 85316-10097; 12 oz plastic container d.) Gracie's
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0338-2025·2025-01-08

    Mixed Fruit Products Recalled for Listeria Contamination Risk

    Gracie's Kitchens Inc. is recalling multiple brands of mixed fruit products due to potential Listeria monocytogenes contamination. Affected products were sold in Connecticut and New York with sell-by dates of November 11-21, 2024.

    Product
    a.) King Kullen brand Mixed Fruit; UPC: 85316-10376; 12 oz plastic container b.) King Kullen brand Mixed Fruit; UPC: 85316-10385; 16 oz plastic container c.) Wild By Nature brand Mixed Fruit; UPC: 85316-10376; 12 oz plastic container d.) Wild By Nature brand Mixed Fruit; UPC: 853
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0779-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled for Non-Sterile Components

    Medline is recalling custom surgical procedure kits containing non-sterile surgical components with potential endotoxin contamination. The recall affects 1,402 units distributed in the US, Canada, and UAE.

    Product
    Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ56819F; 5) BURR HOLE SHUNT PACK, REF DYNJ56819G; 6) RO VP SH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2025·2025-01-08

    Medline Deep Brain Stimulation Surgical Kits Recalled for Non-Sterile Contamination

    Medline has recalled 128 Deep Brain Stimulation surgical kits for containing non-sterile Surgical Patties and Strips with potential endotoxin contamination. Affected units were distributed worldwide including the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0365-2025·2025-01-08

    Sam's Club Hatch Chile Chicken Enchiladas Recalled for Listeria

    Sam's Club is recalling Member's Mark Hatch Chile Chicken Enchiladas because the product may contain Listeria monocytogenes.

    Product
    Member's Mark Hatch Chile Chicken Enchiladas, ready to cook, perishable, packaging type: aluminum/black oven-safe tray Net wt. variable - average 1.52 lbs. UPC 00226529000004, UPC 00409802813793
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0772-2025·2025-01-08

    SynchroMed II and III implantable pumps recalled for software issues

    Medtronic recalled SynchroMed II and III implantable pumps for software issues in the clinician tablet application. Fifty-nine systems are affected.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0334-2025·2025-01-08

    King Kullen Tri Colored Noodles Recalled for Possible Listeria Contamination

    King Kullen brand Tri Colored Noodles may be contaminated with Listeria monocytogenes. The recall affects 3681 cases distributed in Connecticut and New York with sell-by dates from November 12–22, 2024.

    Product
    a.) King Kullen brand Tri Colored Noodles; UPC: 85316-10146; 14 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0335-2025·2025-01-08

    Mirepoix Recall Due to Potential Listeria Contamination

    Gracie's Kitchens Inc. is recalling certain Mirepoix products sold under the King Kullen and Gracie's Kitchen brands due to potential Listeria monocytogenes contamination.

    Product
    a.) King Kullen brand Mirepoix; UPC: 85316-10167; 20 oz plastic container b.) Gracie's Kitchen brand Mirepoix; UPC: 85316-10167; 20 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0780-2025·2025-01-08

    Medline custom surgical procedure kits recalled for non-sterile components and endotoxin contamination

    Medline custom procedure kits containing non-sterile Codman Surgical Patties & Strips are being recalled due to potential endotoxin contamination. The recall affects 74 units distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYNJ910120
    Category
    Medical Device
    Distribution
    Distributed nationwide