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.

8726–8750 of 22113

  • 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-0774-2025·2025-01-08

    SynchroMed II and III Implantable Pumps Recalled for Software Issues

    Medtronic has recalled 3,981 SynchroMed implantable pumps worldwide due to software issues in application version 2.x used to program the devices.

    Product
    SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0784-2025·2025-01-08

    Medline Custom Surgical Procedure Kits Recalled for Potential Endotoxin Contamination

    Medline Industries is recalling custom medical procedure kits due to non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. Approximately 1,072 units were distributed in the US, Canada, and UAE.

    Product
    Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; 3) ENT ENDO SINUS WILMINGTON PACK, REF DYNJ66447; 4) ENDOSCOPIC SKULL BASE, REF DYNJ58648D; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648J.
    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 (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
  • HighNHTSA·23V596000·2025-01-08

    2023 Ford Edge Front Right Headlight May Be Too Bright or Misaimed

    Ford is recalling certain 2023 Edge vehicles. The front right headlight may be too bright or aimed incorrectly, which may cause glare and increase crash risk.

    Product
    FORD — 2023 FORD EDGE
    Category
    Vehicle
    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
  • 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-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-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 (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 (Food)·F-0343-2025·2025-01-08

    King Kullen and Gracie's Kitchen Tropical Delight Bowls recalled for potential Listeria contamination

    Gracie's Kitchens Inc. is recalling Tropical Delight Bowls distributed in Connecticut and New York due to potential Listeria monocytogenes contamination. Affected products have sell-by dates of November 11–21, 2024.

    Product
    a.) King Kullen brand Tropical Delight Bowl; UPC: 85316-10391; 28 oz plastic container b.) Gracie's Kitchen brand Tropical Delight Bowl; UPC: 85316-10313; 28 oz plastic container c.) Gracie's Kitchen brand Tropical Delight Bowl; UPC: 85316-10391; 28 oz plastic container
    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 (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 (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-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 (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
  • HighNHTSA·23V601000·2025-01-08

    Audi recalls 2021 A6 and other models for incorrectly labeled brake cap

    Audi is recalling certain 2019-2021 A6 and A7 models, plus 2021 A6 Allroad and S-series models, for an incorrectly labeled brake fluid cap that could result in reduced braking ability.

    Product
    AUDI — 2021 AUDI A6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V598000·2025-01-08

    Rearview camera may fail on Lincoln Navigator and other Ford vehicles

    Ford is recalling certain 2018-2023 Lincoln Navigator and Aviator vehicles, 2022-2023 Ford Transit, and 2021 Ford Bronco vehicles. The rearview camera may fail to display when reversing, reducing visibility and increasing crash risk.

    Product
    LINCOLN — 2020 LINCOLN NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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-0342-2025·2025-01-08

    Halo Bowl Recalled Due to Potential Listeria Monocytogenes Contamination

    Three brands of Halo Bowl (King Kullen, Wild by Nature, Gracie's Kitchen) are recalled for potential Listeria monocytogenes contamination. Affected products sold in CT and NY with Sell By dates 11/11–11/21/24.

    Product
    a.) King Kullen brand Halo Bowl; UPC: 85316-10390; 28 oz plastic container b.) Wild by Nature brand Halo Bowl; UPC: 85316-10390; 28 oz plastic container c.) Gracie's Kitchen brand Halo Bowl; UPC: 85316-10312; 28 oz plastic container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0321-2025·2025-01-08

    An Pan Buns Lack Sesame Allergen Declaration on Label

    Oyatsupan Bakers is recalling An Pan buns because the allergen declaration doesn't list sesame, though black sesame seeds are visible and listed in ingredients. Distribution was limited to Oregon and Washington.

    Product
    An Pan bun is a sweet roll filled with sweet red bean paste, stamped with black sesame seeds on top. Product is packaged in clear polypropylene bag, heat sealed with white labels on front and back. Net wt. 2.9pz. UPC 854077007055. The affected label states "**INGREDIENTS: Azuki
    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