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.

5801–5825 of 52958

  • HighNHTSA·25V007000·2025-01-13

    Winnebago spare tire carrier mounting bolts may loosen and detach

    Winnebago is recalling certain 2025 Minnie Winnie and Spirit motorhomes because the spare tire carrier mounting bolts may loosen, allowing the carrier to detach.

    Product
    WINNEBAGO — WINNEBAGO SPIRIT, MINNIE WINNIE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V006000·2025-01-13

    Kia Sorento software error may disable low beams and taillights

    Kia is recalling certain 2024-2025 Sorento vehicles because a Body Domain Control Unit software error may cause a loss of low beam headlights and taillights.

    Product
    KIA — KIA SORENTO, SORENTO PHEV, SORENTO HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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-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-0336-2025·2025-01-08

    Watermelon Bowl Products Recalled for Potential Listeria Contamination

    Gracie's Kitchens Inc. is recalling King Kullen and Gracie's Kitchen branded Fiesta Watermelon Bowl products due to potential Listeria monocytogenes contamination. Affected products were distributed in Connecticut and New York.

    Product
    a.) King Kullen brand Fiesta Watermelon Bowl; UPC: 85316-10200; 60 oz plastic container b.) Gracie's Kitchen brand Fiesta Watermelon Bowl; UPC: 85316-10202; 60 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0174-2025·2025-01-08

    Injectable phenylephrine recalled due to defective tamper-evident seals nationwide

    Hikma Injectables is recalling phenylephrine injections nationwide because tamper-evident seals on some syringes were not properly attached. Affected lot 243120003D has a use-by date of 03/11/2025.

    Product
    phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
    Category
    Drug
    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-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 (Drugs)·D-0172-2025·2025-01-08

    Dapsone Topical Gel Recalled Due to Crystallization Defect

    Viona Pharmaceuticals is recalling Dapsone Gel 7.5% (2760 packs) distributed nationwide due to crystallization in the formulation. The voluntary recall affects lots T400514 and T400808.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Food)·F-0332-2025·2025-01-08

    Fajita Mix Products Recalled for Potential Listeria Contamination

    Gracie's Kitchens Inc. is recalling King Kullen and Gracie's Kitchen brand Fajita Mix products distributed in Connecticut and New York due to potential Listeria monocytogenes contamination.

    Product
    a.) King Kullen brand Fajita Mix; UPC: 85316-11090; 12 oz plastic container b.) Gracie's Kitchen brand Fajita Mix; UPC: 85316-10002; 12 oz plastic container
    Category
    Food
    Distribution
    2 states
  • 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 (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-0352-2025·2025-01-08

    Gracie's Kitchen Broccoli Florets Recalled for Possible Listeria Contamination

    Gracie's Kitchen brand Broccoli Florets are being recalled due to possible contamination with Listeria monocytogenes. The recall affects 3,681 cases distributed in Connecticut and New York with sell-by dates between November 14-24, 2024.

    Product
    a.) Gracie's Kitchen brand Broccoli Florets; UPC: 85316-10011; 12 oz foam tray
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0800-2025·2025-01-08

    Surgical Nasal Packing Devices Recalled for Sterile Barrier Defect

    Carwild is recalling Ivalon Anatomical Nasal Packing devices because the package seal may be defective, leaving the sterile barrier unable to be guaranteed. Lot 24F1638 with approximately 140 units was distributed across multiple U.S. states and internationally.

    Product
    Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q770410
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-0362-2025·2025-01-08

    Beef & Lamb Gyro Meal Kit Recalled for Salmonella Risk

    Reser's Fine Foods is recalling Beef & Lamb Gyro Sandwich Express Meal Kits due to potential Salmonella contamination in the tzatziki sauce. The recall affects 5,271 cases distributed across 19 states.

    Product
    Beef & Lamb Gyro Sandwich Express Meal Kit. Net wt. 31.8oz. UPC 0 13454 38313 1. Each kit contains 6 Pitas, Gyro Meat, Tzatziki Sauce 3oz. cups, Fire Feta Sauce, Feta Cheese Crumbles. Packaged in clear plastic clamshell. Distributed by Fresh Creative Foods, Vista CA.
    Category
    Food
    Distribution
    19 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-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-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 (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 (Food)·F-0331-2025·2025-01-08

    Peppers & Onions Products Recalled for Listeria Contamination Risk

    Multiple brands of peppers & onions products are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in Connecticut and New York.

    Product
    a.) King Kullen brand Peppers & Onions; UPC: 85316-10087; 12 oz plastic container b.) Wild by Nature brand Peppers & Onions; UPC: 85316-10087; 12 oz plastic container c.) Gracie's Kitchen brand Peppers & Onions; UPC: 85316-10001; 12 oz plastic container d.) Gracie's Kitchen brand
    Category
    Food
    Distribution
    2 states
  • 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-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
  • 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