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.

5826–5850 of 52958

  • 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-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
  • HighNHTSA·25V004000·2025-01-08

    Blue Bird Recalls 2025 All American Bus for Wiring Defect

    Blue Bird is recalling one 2025 All American transit bus because incorrect wiring reverses high and low beams, potentially blinding other drivers.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS
    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-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 (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-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-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 (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 (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 (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-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 (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
  • 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-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 (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-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-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-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 (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 (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 (Devices)·Z-0799-2025·2025-01-08

    Surgical spears recalled for potential sterile barrier defect

    Carwild Corporation recalls 300 Ivalon cellulose surgical spears (Model Q604237) due to potential package seal defects that could compromise sterility during ophthalmic surgical procedures.

    Product
    Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
    Category
    Medical Device
    Distribution
    5 states