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.

7751–7775 of 26961

  • HighFDA (Food)·F-0341-2025·2025-01-08

    Tropical Fruit Cup Products Recalled for Possible Listeria Contamination

    King Kullen and Gracie's Kitchen brand tropical fruit cups may contain Listeria monocytogenes. Affected products were distributed in Connecticut and New York with sell-by dates from 11/11 to 11/21/24.

    Product
    a.) King Kullen brand Tropical Fruit Cup; UPC: 85316-10384; 16 oz plastic container b.) King Kullen brand Tropical Fruit Cup; UPC: 85316-10403; 12 oz plastic container c.) Gracie's Kitchen brand Tropical Fruit Cup; UPC: 85316-10384; 16 oz plastic container d.) Gracie's Kitchen br
    Category
    Food
    Distribution
    2 states
  • 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-0324-2025·2025-01-08

    Multiple pineapple products recalled for potential Listeria contamination

    Gracie's Kitchens Inc. is recalling pineapple products sold under King Kullen, Wild By Nature, and Gracie's Kitchen brands in Connecticut and New York due to potential Listeria monocytogenes contamination.

    Product
    a.) King Kullen brand Pineapple Slices; UPC 85316-10007; 20 oz foam tray b) Wild By Nature brand Pineapple Slices; UPC: 85316-10007; 20 oz foam tray c.) King Kullen brand Pineapple Chunks; UPC: 85316-10386; 16 oz plastic container d.) King Kullen brand Pineapple Spears; UPC: 8531
    Category
    Food
    Distribution
    2 states
  • 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 (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 (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-0355-2025·2025-01-08

    Gracie's Kitchen Mango & Blueberry Cup Recalled for Possible Listeria Contamination

    Gracie's Kitchen brand Mango & Blueberry Cup may be contaminated with Listeria monocytogenes. The recall affects 3,681 cases distributed in Connecticut and New York.

    Product
    a.) Gracie's Kitchen brand Mango & Blueberry Cup; UPC: 85316-10347; 12 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-0350-2025·2025-01-08

    Fruit Spears from Multiple Brands Recalled for Listeria Contamination

    Gracie's Kitchens Inc. is recalling Wild by Nature and Gracie's Kitchen brand Fruit Spears due to potential Listeria monocytogenes contamination. Affected products were distributed in Connecticut and New York with sell-by dates from November 11 to November 21, 2024.

    Product
    a.) Wild by Nature brand Fruit Spears; UPC: 85316-10393; 24 oz plastic container b.) Gracie's Kitchen brand Fruit Spears; UPC: 85316-10393; 24 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0323-2025·2025-01-08

    Multiple watermelon brands recalled due to Listeria contamination risk

    Gracie's Kitchens Inc. is recalling watermelon products from multiple brands due to potential Listeria monocytogenes contamination. Affected products were sold in Connecticut and New York with sell-by dates from November 9-21, 2024.

    Product
    a.) King Kullen brand Watermelon Slices; UPC 85316-10006; 20 oz foam tray b) Wild By Nature brand Watermelon Slices; UPC: 85316-10006; 20 oz foam tray c.) King Kullen brand Watermelon Chunks; UPC: 85316-10413; 12 oz plastic container d.) King Kullen brand Watermelon Slices; UPC:
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0794-2025·2025-01-08

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

    Medline is recalling 474,300 custom surgical procedure kits because they contain non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. These components could pose infection risks during surgical procedures.

    Product
    Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) CRANIOFACIAL CDS, REF CDS780102L; 4) CRANIOFACIAL CDS, REF CDS780102M; 5) CRANIOTOMY CDS-LF, REF CDS780105K; 6) CRANIOTOMY CDS-LF, REF CDS780105L; 7) CRANIO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0329-2025·2025-01-08

    Diced White Onions Recalled for Potential Listeria Contamination

    Gracie's Kitchens Inc. is recalling diced white onion products due to potential Listeria monocytogenes contamination. Multiple brands (King Kullen, Wild By Nature, Gracie's Kitchen) are affected; products were distributed in Connecticut and New York.

    Product
    a.) King Kullen brand Diced White Onion; UPC: 85316-10083; 12 oz plastic container b.) Wild By Nature brand Diced White Onion; UPC: 85316-10085; 12 oz plastic container c.) Gracie's Kitchen brand Diced White Onion; UPC: 85316-10018; 10 oz plastic container d.) Gracie's Kitchen br
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0349-2025·2025-01-08

    Gracie's Kitchens and Wild by Nature Mixed Peppers Recalled for Listeria

    Gracie's Kitchens and Wild by Nature brand sliced and diced mixed peppers may be contaminated with Listeria monocytogenes. The recall affects products distributed in Connecticut and New York.

    Product
    a.) Wild by Nature brand Sliced Mixed Peppers; UPC: 85316-10102; 12 oz plastic container b.) Gracie's Kitchen brand Sliced Mixed Peppers; UPC: 85316-10007; 12 oz plastic container c.) Gracie's Kitchen brand Diced Tri Color Peppers; UPC: 85316-10023; 10 oz plastic container d.) Gr
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0330-2025·2025-01-08

    Gracie's Kitchens Diced Red Onion Recalled for Potential Listeria Contamination

    Diced red onion products from multiple brands manufactured by Gracie's Kitchens Inc. have been recalled due to potential Listeria monocytogenes contamination. The recall affects products distributed in Connecticut and New York.

    Product
    a.) King Kullen brand Diced Red Onion; UPC: 85316-10086; 12 oz plastic container b.) Wild By Nature brand Diced Red Onion; UPC: 85316-10086; 12 oz plastic container c.) Gracie's Kitchen brand Diced Red Onion; UPC: 85316-10017; 10 oz plastic container d.) Gracie's Kitchen brand Di
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0345-2025·2025-01-08

    Fruit Trays Recalled Due to Potential Listeria Contamination

    Multiple brands of fruit trays sold in Connecticut and New York are being recalled due to potential Listeria monocytogenes contamination. Consumers should not eat the affected products.

    Product
    a.) King Kullen brand Fruit Tray; UPC: 85316-10398; 42 oz plastic container b.) King Kullen brand Fruit Tray; UPC: 85316-10399; 1.65 plastic container c.) WIld by Nature Fruit Tray; UPC: 85316-10398; 42 oz plastic container d.) Wild by Nature Fruit Tray: UPC: 85316-10399; 1.65lb
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0786-2025·2025-01-08

    Medline Custom Surgical Kits Recalled for Non-Sterile Components with Endotoxin Risk

    Medline Industries is recalling 3,903 custom medical procedure kits due to non-sterile Codman Surgical Patties and Strips with potential for endotoxin contamination. The recall affects products distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE FLAP PACK-LF, REF DYNJ42833B; 4) TYMPANOPLASTY PACK, REF DYNJ50692C; 5) MAJOR CRANIOTOMY SAFETY, REF DYNJ54736B; 6) FREE FLAP CU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0787-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled Due to Sterility Concerns

    Medline is recalling custom surgical procedure kits that contain non-sterile surgical supplies with potential for endotoxin contamination. The kits were distributed worldwide, including the United States, United Arab Emirates, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J; 2) NEURO BASIN KIT, REF DYNJ80200B.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2025·2025-01-08

    Medtronic SynchroMed II and III Implantable Pumps Recalled for Software Defects

    Medtronic is recalling SynchroMed II and III implantable pumps used with a clinician tablet app that has software issues in version 2.x. Approximately 319 systems were distributed worldwide.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0777-2025·2025-01-08

    Medline surgical procedure kits recalled for non-sterile supplies

    Medline is recalling custom medical procedure kits containing non-sterile surgical supplies with potential endotoxin contamination. The affected kits were distributed nationwide and internationally.

    Product
    Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYNJ66252A; 5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0325-2025·2025-01-08

    Cantaloupe products recalled due to potential Listeria monocytogenes contamination

    Gracie's Kitchens Inc. is recalling cantaloupe slices and chunks sold under King Kullen, Wild By Nature, and Gracie's Kitchen brands due to potential Listeria monocytogenes contamination. Products were distributed in Connecticut and New York.

    Product
    a.) King Kullen brand Cantaloupe Slices; UPC 85316-10008; 20 oz foam tray b) Wild By Nature brand Cantaloupe Slices; UPC: 85316-10008; 20 oz foam tray c.) King Kullen brand Cantaloupe Chunks; UPC: 85316-10379; 12 oz plastic container d.) King Kullen brand Cantaloupe Chunks; UPC:
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0339-2025·2025-01-08

    Mango Products Recalled for Potential Listeria Contamination

    Multiple mango brands sold in Connecticut and New York are being recalled due to potential Listeria monocytogenes contamination. Consumers should discard affected products or return them to retailers.

    Product
    a.) King Kullen brand Mango; UPC: 85316-10377; 12 oz plastic container b.) King Kullen brand Mango Spears; UPC: 85316-10387; 16 oz plastic container c.) Wild by Nature brand Mango; UPC: 85316-10377; 12 oz plastic container d.) Gracie's Kitchen brand Mango Spears; UPC: 85316-10337
    Category
    Food
    Distribution
    2 states
  • 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 (Devices)·Z-0782-2025·2025-01-08

    Medical Device Kits Recalled for Non-Sterile Surgical Components

    Medline Industries is recalling See DocMan custom convenience kits that contain non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. Approximately 48,655 units were distributed worldwide.

    Product
    See DocMan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-0797-2025·2025-01-08

    3M Unitek Orthodontic Primer Recalled Due to Bond Failures and Skin Irritation

    3M Unitek is recalling Transbond Plus Self-Etching Primer used in orthodontic bonding due to reports of bracket bond failures and skin irritation or blistering.

    Product
    3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.
    Category
    Medical Device
    Distribution
    Distributed nationwide