The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

1551–1575 of 4878

  • SevereFDA (Food)·F-0669-2024·2023-12-13

    Mixed Fruit with Grapes Recalled for Potential Salmonella Contamination

    FreshPoint Bix Produce Company is recalling Mixed Fruit with Grapes products due to potential Salmonella contamination. Affected products were distributed in Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    Bix Produce Mixed Fruit with Grapes products containing Cantaloupe, Honeydew, Pineapple, and Red Grapes. Keep Refrigerated. Manufactured and Distributed by: Bix Produce Company, 3060 Centerville Road, Little Canada, MN 55117 Packaged with the following cuts and weights:
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0612-2024·2023-12-13

    Freshly Made Signature Fruit Bowl Recalled for Salmonella

    Market Cuts LLC is recalling Freshly Made Signature Fruit 32oz bowls due to potential Salmonella contamination. Products affected have Best By dates 11/4/2023 to 11/9/2023 and were distributed in IL, IN, MI, and WI.

    Product
    Freshly Made Signature Fruit 32oz bowl UPC 092538002298
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0609-2024·2023-12-13

    Cantaloupe Chunks Recalled for Salmonella Risk, Class I

    Market Cuts LLC initiated a recall of cantaloupe chunks sold under the Little Salad Bar and Market Cuts brands due to potential Salmonella contamination. Affected products were distributed in Illinois, Indiana, Michigan, and Wisconsin.

    Product
    Little Salad Bar Cantaloupe Chunks, 1lb clamshell UPC 4099100215885; Market Cuts Cantaloupe Chunk 1" 1/5lb Tray, 5lb tray; Market Cuts1 lb Cantaloupe Chunk 1"x1", 1lb clamshell UPC 092538001277; Market Cuts Cantaloupe Chunk 1" 2/5lb Tray, 5lb tray; Market Cuts Cantaloupe Chunk 3
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0672-2024·2023-12-13

    Bix Produce Mixed Fruit Recall for Potential Salmonella Contamination

    FreshPoint Bix Produce Company is recalling Item #12217 mixed fruit (cantaloupe, pineapple, red grapes) due to potential Salmonella contamination. The product was distributed in Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    Bix Produce Item # 12217 Fruit, Chk Cant/Pine 1/2" w/Grp, 5 lb. containing Cantaloupe, Pineapple, and Red Grapes. Keep Refrigerated. Manufactured and Distributed by: Bix Produce Company, 3060 Centerville Road, Little Canada, MN 55117
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0613-2024·2023-12-13

    Food recall: Salmonella contamination in ready-made melon bowls

    Market Cuts LLC is recalling Freshly Made Signature Melon bowls (28oz) due to potential Salmonella contamination affecting products distributed in Illinois, Indiana, Michigan, and Wisconsin.

    Product
    Freshly Made Signature Melon 28oz bowl UPC 092538002274
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0138-2024·2023-12-13

    Dietary supplement recalled for unapproved drug status and pharmaceutical contamination

    Dr. Ergin's SugarMD glucose support capsules are recalled nationwide because they were marketed without FDA approval and are contaminated with the pharmaceutical ingredients metformin and glyburide. Approximately 32,117 units were distributed in the U.S.

    Product
    Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL 34
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0144-2024·2023-12-13

    FDA Recalls SANDIMMUNE Oral Solution Due to Crystallization

    Novartis Pharmaceuticals is recalling SANDIMMUNE Oral Solution (cyclosporine 100 mg/mL) due to crystallization found in bottles. The affected lots were distributed nationwide.

    Product
    SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0611-2024·2023-12-13

    Food Recall: Market Cuts Fruit Mix Products Due to Salmonella

    Market Cuts LLC is recalling fruit mix products distributed in Illinois, Indiana, Michigan, and Wisconsin due to salmonella. The voluntary recall, initiated November 9, 2023, affects 434 units with best-by dates from November 4–9, 2023.

    Product
    Market Cuts Fruit Mix Standard 1/5lb Tray 5 Pound tray; Market Cuts 1 lb Fruit Mix Chunk 1" 1 Pound clamshell UPC 092538000461; Market Cuts Fruit Mix Standard 2/5lb Tray 5 Pound tray; Market Cuts 20 oz Bowl Fruit Small 20 Ounce bowl UPC 092538000577; Freshly Made Mixed Fruit 10 O
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0670-2024·2023-12-13

    Mixed Fruit Products Recalled for Potential Salmonella Contamination

    Bix Produce Mixed Fruit products containing cantaloupe, honeydew, and pineapple are recalled due to potential Salmonella contamination. Consumers should not consume the affected products.

    Product
    Bix Produce Mixed Fruit products containing Cantaloupe, Honeydew, and Pineapple. Keep Refrigerated. Manufactured and Distributed by: Bix Produce Company, 3060 Centerville Road, Little Canada, MN 55117 Packaged with the following cuts and weights: 1. Item # 12192, Fruit
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0420-2024·2023-12-13

    CARDIOHELP Emergency Drive Blockage May Impair Cardiac Blood Oxygenation

    The FDA is recalling CARDIOHELP Emergency Drive units due to potential blocking that impairs blood flow. Affected patients may experience ischemia and hypoxia from inappropriate low blood oxygen.

    Product
    CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0614-2024·2023-12-13

    Fruit Combo Trays Recalled for Possible Salmonella Contamination

    Market Cuts fruit combo trays (40 oz and 80 oz) are recalled due to possible salmonella contamination. Affected products were distributed in Illinois, Indiana, Michigan, and Wisconsin between November 4–9, 2023.

    Product
    Market Cuts 40 oz Combo Tray Fruit Small 40 Ounce tray UPC 092538001611; (No brand) 80 oz Combo Tray Fruit Large 80 Ounce tray UPC 092538001604; (No brand) 40 oz Combo Tray Fruit Small 40 Ounce tray UPC 092538001611; Market Cuts 80 oz Combo Tray Fruit Large 80 Ounce tray UPC 0925
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0355-2024·2023-12-13

    Infusomat Administration Sets recalled for tubing dimension defects

    B. Braun Infusomat Administration Sets may have incorrect tubing dimensions that cause false air-in-line alarms, interrupting medication delivery. The defects may prevent critical medications from reaching patients.

    Product
    Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; 362034 Priming volume: 19mL, le
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0615-2024·2023-12-13

    Market Cuts Fruit Trays with Cream Cheese Recalled for Salmonella

    Market Cuts LLC voluntarily recalled 40 oz and 80 oz Combo Tray Fruit products with cream cheese due to potential Salmonella contamination. The recall affected products distributed in Illinois, Indiana, Michigan, and Wisconsin.

    Product
    Market Cuts 40 oz Combo Tray Fruit Small w/ Cream Cheese 40 Ounce tray UPC 092538002755; Market Cuts 80 oz Combo Tray Fruit Large w/ Cream Cheese 80 Ounce tray UPC 092538002748
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0667-2024·2023-12-13

    Mixed Fruit Cups Recalled for Potential Salmonella Contamination

    FreshPoint Bix Produce Company is recalling Mixed Fruit Cups due to potential Salmonella contamination. The recall affects 432 units distributed in Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    Mixed Fruit Cup, clam-shell container. Net Wt 5.75 oz (163g). Keep Refrigerated. Ingredients: Cantaloupe, Honeydew, Pineapple, Red Grapes. Manufactured and Distributed by: Bix Produce Company, 3060 Centerville Road, Little Canada, MN 55117 Packaged with the following
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0610-2024·2023-12-13

    Pineapple Products from Market Cuts Recalled for Possible Salmonella Contamination

    Market Cuts is recalling multiple pineapple products due to potential Salmonella contamination. The recall affects products distributed in Illinois, Indiana, Michigan, and Wisconsin.

    Product
    Market Cuts 1 lb Pineapple Spear 1 Pound clamshell UPC 092538001239; Market Cuts 1 lb Pineapple Chunk 1"x1" 1 Pound clamshell UPC 092538001284; Market Cuts Pineapple Chunk 1" 2/5lb Tray 5 Pound tray; Market Cuts Pineapple Chunk 1" 1/5lb Tray 5 Pound tray; Market Cuts 6 oz Pinea
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0665-2024·2023-12-13

    FreshPoint Bix Produce Company Cantaloupe Recall Due to Salmonella Risk

    FreshPoint Bix Produce Company is recalling whole cantaloupes due to potential Salmonella contamination. The recall affects approximately 186 packs distributed across Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    FreshPoint Bix Produce Company, Whole Cantaloupe, Item 03143. 1/3 CT. 3 melons per container.
    Category
    Food
    Distribution
    4 states
  • SevereCPSC·24048·2023-12-07

    XpressGoods recalls magnetic balls for federal toy safety violations

    XpressGoods is recalling colorful neodymium magnetic balls that exceed federal safety limits for toy magnets. When swallowed, the magnets can lodge in the digestive system and cause serious injury or death.

    Product
    Colorful Metal Neodymium Magic Magnetic Balls - 8 color, 5mm
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·24727·2023-12-07

    2022 Fugleman UT10E and UT10X Utility-Terrain Vehicles Fire Hazard Recall

    Segway Powersports is recalling about 1,100 2022 Fugleman UT10E and UT10X Utility-Terrain Vehicles because the ignition coil can fail, allowing fuel to enter the exhaust pipe and ignite, creating a fire hazard. One vehicle fire with property damage has been reported.

    Product
    2022 Fugleman UT10E and UT10X Utility-Terrain Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0145-2024·2023-12-06

    Prescription drug oral solution recalled for microbial contamination

    Bayer Healthcare Pharmaceuticals Inc. is recalling 192 bottles of VITRAKVI (larotrectinib) oral solution due to microbial contamination identified as Penicillium brevicompactum during routine testing.

    Product
    VITRAKVI — VITRAKVI (LAROTRECTINIB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0225-2024·2023-12-06

    Reumo Flex caplets recalled for undeclared diclofenac content nationwide

    Reumo Flex caplets packaged in 30-count boxes are being recalled because they contain undeclared diclofenac and were marketed without FDA approval. The product was distributed nationwide.

    Product
    Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0473-2024·2023-12-06

    Tuna Salad Recalled for Undeclared Milk and Soy Allergens

    Le Croissant Tuna Salad (5.8oz) is recalled due to undeclared milk and soy allergens. Consumers with allergies to these allergens should not consume the product.

    Product
    Le Croissant Tuna Salad Net Wt. 5.8oz (164g) UPC:766375261605 Packaged in clamshell container. Sold under Food Unlimited brand. Sold as single unit and 6-unit pack
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0480-2024·2023-12-06

    GreenGate Fresh Spinach Recalled for Potential E. coli Contamination

    GreenGate Fresh Cello Spinach is being recalled due to potential E. coli (EHEC) contamination. The recall involves 11 cases distributed to eight consignees across seven U.S. states.

    Product
    GreenGate Fresh Standard Cello Spinach; 4 - 2.5lb plastic bags per box; SKU 465; Perishable hence require refrigeration at all times of its shelflife
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0224-2024·2023-12-06

    FDA recalls Artri King tablets for undeclared diclofenac

    Botanical Be is recalling 235 bottles of Artri King tablets sold nationwide. The tablets contain undeclared diclofenac and were marketed without FDA drug approval.

    Product
    Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0476-2024·2023-12-06

    Eltahan Golden Raisins 400g recalled for undeclared sulfites

    Eltahan Inc. is recalling Eltahan Golden Raisins (400g, UPC 2337660022) distributed in NY, NJ, and PA due to undeclared sulfites, which can cause severe allergic reactions.

    Product
    Eltahan Golden Raisins 400 gm. Packaged in a clear plastic bag. UPC 2337660022
    Category
    Food
    Distribution
    3 states