The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

13776–13800 of 27263

  • 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-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-0569-2024·2023-12-13

    Rudy brand whole cantaloupes recalled due to possible Salmonella contamination

    Sofia Produce, L.L.C. is recalling Rudy brand whole cantaloupes distributed across the United States and Canada due to possible Salmonella contamination.

    Product
    Whole cantaloupe, Brand name Rudy 11 count carton, 8 count carton, 9 count carton, 15 count carton d. Container description; Cardboard containers bearing the Rudy label. The Rudy brand cantaloupes also have an individual PLU sticker placed upon each cantaloupe, PLU sticker # 405
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0668-2024·2023-12-13

    Bix Produce Cut Cantaloupe Recalled for Potential Salmonella Contamination

    FreshPoint Bix Produce Company is recalling 1,355 units of cut cantaloupe products due to potential Salmonella contamination. Products were distributed in Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    Bix Produce Cut Cantaloupe. 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 # 12064, Fruit, Balls small Cantaloupe, 5 lb. 2. Item # 12070, Fru
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0666-2024·2023-12-13

    FreshPoint Bix Produce Cantaloupe Fruit Cup Recalled for Potential Salmonella

    FreshPoint Bix Produce Company is recalling specific lots of Cantaloupe Fruit Cup (Item 19703) due to potential Salmonella contamination. Affected products were distributed to Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    Cantaloupe Fruit Cup, Item 19703. clam-shell container. Net Wt 5.75 oz (163g). UPC 8 46709-00523 2. Manufactured and Distributed by: Bix Produce Company, 3060 Centerville Road, Little Canada, MN 55117
    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-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 (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-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 (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 (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-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 (Food)·F-0617-2024·2023-12-13

    Whole Cantaloupe Recalled for Potential Salmonella Contamination

    TruFresh in Nogales, AZ has issued a voluntary recall of whole cantaloupe sourced from Malichita, Mexico, due to potential Salmonella contamination.

    Product
    Whole cantaloupe 3ct and 6ct
    Category
    Food
    Distribution
    0 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 (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-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
  • 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
  • HighFDA (Devices)·Z-0457-2024·2023-12-13

    Biliary balloon dilators recalled due to design nonconformity and detachment risk

    Wilson-Cook Medical recalled 731 QUANTUM TTC biliary balloon dilators due to design nonconformity that could cause balloon detachment. The device failure may require endoscopic retrieval and risks bleeding complications.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0442-2024·2023-12-13

    Medical Radiation Therapy Device Microswitch May Cause Uncontrolled Detector Arm Extension

    Elekta radiation therapy accelerators may experience uncontrolled detector arm extension due to an incorrectly set microswitch in the middle arm. The issue affects 315 units worldwide.

    Product
    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0489-2024·2023-12-13

    BAPS Shayona Kaju Katri Cashew Fudge Recalled for Undeclared Yellow #5 Dye

    BAPS Shayona Kaju Katri Kesar (cashew fudge with saffron) is being recalled because it contains undeclared Yellow #5 dye. The product was distributed to Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    BAPS SHAYONA Kaju Katri Kesar Cashew fudge flavored with saffron Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53065 Contains: Nut
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0504-2024·2023-12-13

    Medical Catheter Sets Recalled Due to Bonding Material Defect

    CooperSurgical H/S Catheter Sets may have defective bonding material causing component detachment or leakage. The sets are used in hysterosalpingography procedures to detect uterine abnormalities.

    Product
    CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2024·2023-12-13

    HeartWare HVAD Ventricular Assist Device Documentation Update

    HeartWare is updating documentation for 380 HVAD cardiac assist devices to clarify Controller Fault alarm conditions and device lifetime instructions.

    Product
    STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0499-2024·2023-12-13

    Milled Golden Flax Recalled for Plastic Foreign Object Contamination

    Scoular Grain Co is recalling Milled Golden Flax MGDF in 50 lb bags due to plastic foreign object contamination. Affected lot numbers REG23261 and REG23268 were distributed to Texas and Canada.

    Product
    Milled Golden Flax MGDF, 50 lb bag
    Category
    Food
    Distribution
    0 states