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.

5851–5875 of 52958

  • 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 (Devices)·Z-0778-2025·2025-01-08

    Medline Surgical Procedure Kits Recalled for Endotoxin Contamination Risk

    Medline Industries is recalling 2344 custom surgical kits with non-sterile components that may contain endotoxins. The kits were distributed in the US, UAE, and Canada.

    Product
    Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDYNJ901203D; 6) ACDF-LF, REFDYNJ906681B; 7) ACDF-LF, REFDY
    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-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 (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
  • HighCPSC·25088·2025-01-08

    Children's Bike Helmets Recalled for Failure to Meet Federal Safety Standards

    About 6,500 Wemfg children's bike helmets sold on Amazon fail to comply with federal safety standards for impact protection and stability. The helmets can fail to protect in crashes, posing a risk of head injury.

    Product
    Wemfg Children's Multi-Purpose Bike Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • 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 (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 (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 (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-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-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-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 (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 (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-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-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-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-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 (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-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-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 (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