The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

8751–8775 of 22113

  • HighFDA (Drugs)·D-0173-2025·2025-01-08

    Ketamine injection syringes recalled due to missing tamper-evident seals

    Hikma Injectables is recalling 1,800 ketamine injection syringes nationwide because tamper-evident seals are not attached to several syringes, compromising sterility assurance.

    Product
    ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25
    Category
    Drug
    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-0796-2025·2025-01-08

    Rigid Intracardiac Sucker Units Recalled for Potential Sterility Breach

    Med Michigan Holding recalls SUC-4300S Rigid Intracardiac Suckers due to incomplete or partial pouch seals that may compromise sterility during cardiac surgery.

    Product
    SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.
    Category
    Medical Device
    Distribution
    1 state
  • 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 (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 (Food)·F-0348-2025·2025-01-08

    Wild by Nature Squash Noodles recalled for potential Listeria contamination

    Gracie's Kitchens Inc. is recalling Wild by Nature brand Squash Noodles due to potential Listeria monocytogenes contamination. The recalled product was distributed in Connecticut and New York.

    Product
    a.) WIld by Nature brand Squash Noodles; UPC: 85316-10022; 14 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 (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
  • HighNHTSA·23V597000·2025-01-08

    2023 Ford Explorer turbocharger oil supply line may leak

    Ford is recalling certain 2023 Explorer vehicles with 2.3L GTDI engines because the turbocharger oil supply line may be damaged, causing oil leaks that increase the risk of engine fire or stall.

    Product
    FORD — 2023 FORD EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0785-2025·2025-01-08

    Medline surgical procedure kits recalled for potential endotoxin contamination

    Medline is recalling three custom surgical procedure kits due to non-sterile Codman Surgical Patties and Strips that pose a potential endotoxin contamination risk. The affected kits were distributed in the US, Canada, and the UAE.

    Product
    Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF DYNJ40644A; 3) ENDO SINUS PACK, REF DYNJ66449.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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 (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 (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 (Devices)·Z-0776-2025·2025-01-08

    Baxter Infusion Pump Recalled for Incomplete Post-Repair Testing

    Baxter Healthcare is recalling certain infusion pumps that were released after repair without complete testing. Incomplete testing could affect how the device delivers medication to patients.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0337-2025·2025-01-08

    Gracie's Kitchens Fiesta Bowl Salads Recalled for Listeria Contamination

    Gracie's Kitchens Inc. is recalling three brands of Fiesta Bowl salads (King Kullen, Wild By Nature, and Gracie's Kitchen) sold in Connecticut and New York due to potential Listeria monocytogenes contamination.

    Product
    a.) King Kullen brand Fiesta Bowl; UPC: 85316-10201; 64 oz plastic container b.) Wild By Nature brand Fiesta Bowl; UPC: 85316-10201; 64 oz plastic c.) Gracie's Kitchen brand Fiesta Bowl; UPC: 85316-10214; 60 oz plastic container
    Category
    Food
    Distribution
    2 states
  • 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-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-0368-2025·2025-01-08

    Garden Salad with Dressing Recalled Due to Potential Salmonella Contamination

    Russ Davis Wholesale is recalling garden salads sold under Crazy Fresh and quick & easy brands due to potential Salmonella contamination in cucumbers. Affected products have sell-by dates of November 6-16, 2024.

    Product
    Garden Salad w/Ranch Dressing, Net Wt 9oz. Keep Refrigerated. UPC 7 95831-81023 3. Containing Lettuce, tomatoes, cucumbers, cheddar cheese, carrots and hard cooked egg. Sold under the following brands: 1. Crazy Fresh 2. quick & easy, Ready to Enjoy
    Category
    Food
    Distribution
    11 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-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