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.

12276–12300 of 88183

  • HighFDA (Devices)·Z-2400-2024·2024-07-24

    Infusomat SPACE IV Pump Set Recalled for Backcheck Valve Malfunction

    B. Braun is recalling Infusomat SPACE IV pump sets due to a backcheck valve malfunction that could cause medication to flow backward into the primary IV container and prevent proper priming of the line.

    Product
    Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0612-2024·2024-07-24

    Pravastatin Sodium Tablets Recalled for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling Pravastatin Sodium 80mg tablets nationwide due to failed dissolution specifications. The affected tablets may not dissolve properly, potentially affecting drug absorption.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2410-2024·2024-07-24

    Knee Prosthesis Tibial Component Screws Cannot Be Loosened During Surgery

    The Endo Model M tibial components cannot be loosened during surgery, preventing surgeons from making necessary intraoperative adjustments. This may force unplanned procedure changes.

    Product
    Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1498-2024·2024-07-24

    Canned Coffee Beverage Recalled for Potential Under-Processing Concerns

    Snapchill, LLC is recalling Fire Grounds Coffee Co Mo Mocha canned beverages nationwide due to potential under-processing. Affected cans have expiration dates between June 16, 2024 and April 16, 2025.

    Product
    Black Coffee + Chocolate Syrup and Sugar Canned Beverage packaged under the following brands and sizes: 1. Fire Grounds Coffee Co Mo Mocha, 12 oz. UPC 8 50050-85505 7.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0608-2024·2024-07-24

    Peritoneal Dialysis Solution Recalled for Tube Weld Failure Risk

    Fresenius is recalling DELFLEX dialysis solution due to tube weld failures causing slow leaks that are difficult to detect. 183 cases affected nationwide.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2407-2024·2024-07-24

    Surgical Product Recalled Due to Torn Pouches Compromising Sterile Barrier

    Ethicon Sarl is recalling SURGICEL FIBRILLAR product due to torn foil pouches that compromised the sterile barrier. Approximately 39,010 units distributed in the US, India, and Japan are affected.

    Product
    SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1488-2024·2024-07-24

    Starter Bakery Multigrain Sourdough Bread Recalled for Undeclared Sesame Allergen

    Starter Bakery is recalling Multigrain Sourdough Bread (UPC 8 50025 60902 9) distributed in California because sesame seeds are listed in ingredients but not declared in the allergen warning. People with sesame allergies may unknowingly purchase this product.

    Product
    Starter Bakery Multigrain Sourdough Bread with UPC 8 50025 60902 9
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2370-2024·2024-07-24

    UNITRAX Hip Implant Head Component Recalled for Package Label Size Mismatch

    Howmedica Osteonics is recalling UNITRAX hip implant head components because the package label size may not match the device actually inside, potentially leading to incorrect surgical implantation. Affected units were distributed worldwide.

    Product
    UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1499-2024·2024-07-24

    Canned Black Coffee Beverage Recalled for Potential Under-Processing

    Snapchill, LLC is recalling Larry's Coffee Nitro Sweet(ish) canned beverages due to potential under-processing. The recall affects 549,146 cans distributed nationwide and in Canada, with expiration dates between June 16, 2024 and April 16, 2025.

    Product
    Black Coffee + Sweet Syrup Canned Beverage packaged under the following brands and sizes: 1. Larry's Coffee Nitro Sweet(ish), 12 oz. UPC 8 50050-85511 8.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1502-2024·2024-07-24

    Canned coffee beverages recalled for potential under-processing

    Snapchill LLC is recalling approximately 549,146 cans of ready-to-drink coffee beverages distributed nationwide and in Canada due to potential under-processing.

    Product
    Coffee + Non-Dairy Creamer + Sugar Canned Beverage packaged under the following brands and sizes: 1. Coffee Hound Coffee Co Nitro with Sugar and Non-Dairy Creamer, 12 oz. UPC 7 83970-58494 6. 2. Euphoria Coffee Sweetened Latte, 12 oz. UPC 8 10149-37096 0. 3. Kahawa 1893…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1486-2024·2024-07-24

    Dandelion Chocolate cocoa nibs recalled for undeclared hazelnut allergen

    Dandelion Chocolate is recalling 372 units of chocolate-covered cocoa nibs from California and Nevada due to undeclared hazelnuts. Consumers with hazelnut allergies risk allergic reaction.

    Product
    "feve x DANDELION CHOCOLATE CHOCOLATE - COVERED COCOA NIBS 4 OUNCES 113 GRAMS" Black triangular box with gold lettering. Black box contains cellophane bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2381-2024·2024-07-24

    Infusion pump set backcheck valve malfunction may prevent medication delivery

    B. Braun Medical is recalling an infusion pump set due to potential backcheck valve malfunction that could cause medication to flow backward into IV containers and prevent proper medication administration. The recall affects 3,624 units distributed worldwide.

    Product
    Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2356-2024·2024-07-24

    Cochlear implant devices recalled for potential internal electronics substrate defect

    MED-EL Mi1250 SYNCHRONY 2 cochlear implants may have cracks in their internal electronics substrate that could cause device failure. Seven devices distributed to Durham, North Carolina are affected.

    Product
    Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2351-2024·2024-07-24

    BD Multitest 6-Color TBNK Reagent Contamination May Cause Erroneous Results

    BD Multitest 6-Color TBNK flow cytometry reagent contains contaminated antibodies that may produce erroneous or delayed test results, potentially impacting clinical decisions.

    Product
    BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166; BD Multitest 6-Color TBNK, IVD, REF: 662967; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995. BD Multitest" 6-Color TBNK reagent…
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2378-2024·2024-07-24

    IV Pump Infusion Set Backcheck Valve May Malfunction and Cause Medication Backflow

    B. Braun is recalling the Infusomat UNIV.15DROP PUMP SET (Model 362032) because the backcheck valve may malfunction, allowing medication to flow backward from secondary to primary IV containers, risking medication loss and adverse drug reactions.

    Product
    Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1513-2024·2024-07-24

    Snapchill Quivr Canned Tea Recalled for Potential Under-Processing

    Snapchill, LLC is recalling 549,146 cans of Quivr brand canned tea beverages nationwide due to potential under-processing, which may allow pathogenic contamination.

    Product
    Tea Canned Beverage packaged under the following brands and sizes: 1. Quivr Hibiscus Tea, 12 oz. UPC 8 50032-47603 4. 2. Quivr Jasmine Green Tea, 12 oz. UPC 8 50032-47603 4. 3. Quivr Golden Black Tea, 12 oz. UPC 8 60000-38051 5. 4. Quivr Jade Oolong Tea, 12 oz. UPC…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2350-2024·2024-07-24

    Autotome RX Cannulating Sphincterotome Recalled for Potential Device Malfunction

    Boston Scientific recalls the Autotome RX Cannulating Sphincterotome due to foreign material on the cutting wire that may prevent proper device function and extend procedure time. No injuries reported.

    Product
    Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2376-2024·2024-07-24

    IV infusion set recalled due to backcheck valve malfunction

    B. Braun is recalling OUTLOOK IV sets due to potential backcheck valve malfunction that could allow medication to flow backward between IV containers and prevent proper priming, potentially resulting in patient injury.

    Product
    OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354212
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1509-2024·2024-07-24

    Snapchill Coffee and Oat Milk Beverage Recall Due to Potential Under-Processing

    Snapchill, LLC is recalling 549,146 cans of Coffee + Oat Milk Canned Beverage distributed nationwide and in Canada due to potential under-processing that may not have eliminated harmful organisms.

    Product
    Coffee + Oat Milk Canned Beverage packaged under the following brands and sizes: 1. Dreamy Coffee Co. Hint of Chocolate, 12 oz. 2. Shirazi Distribution Cafe Au Lait - Little Wolf Corree Roasters, 12 oz. UPC 8 50044-13040 5.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2403-2024·2024-07-24

    IV Infusion Pump Set Recalled for Backcheck Valve Malfunction Risk

    B. Braun is recalling the Infusomat UNIV. 15 DROP PUMP SET due to potential backcheck valve malfunction that could cause medication backflow and loss. The defect may result in adverse drug reactions or improper medication delivery.

    Product
    Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 363230
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1482-2024·2024-07-24

    Primal Kitchen Avocado Oil Recalled for Glass Bottle Breakage Risk

    Kraft Heinz Foods Company is recalling Primal Kitchen Avocado Oil in 750ml glass bottles due to potential glass breakage. Affected bottles have Best When Used By dates of August 19-21, 2025.

    Product
    Primal Kitchen Avocado Oil 1PT 9.3 FL OZ (750ml) glass bottle UPC 855232007194, 6 bottles per wholesale case
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-2357-2024·2024-07-24

    Surgical Awl Recalled Due to Insufficient Weld Integrity

    SeaSpine Orthopedics is recalling the Meridian Angled Awl Fixed surgical instrument due to insufficient weld around the cap component that may fail under impaction forces during surgery.

    Product
    Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Drugs)·D-0603-2024·2024-07-24

    Cardura XL Extended Release Tablets Recalled for Failed Impurity Specifications

    Viatris Inc is recalling Cardura XL (doxazosin) extended release tablets 8mg because two lots failed impurity and degradation specifications. Approximately 3,694 bottles were distributed nationwide.

    Product
    Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0598-2024·2024-07-24

    Oatmeal Daily Moisturizing Body Lotion Recalled Due to Mold Contamination

    Brands International Corporation is recalling Oatmeal Daily Moisturizing Body Lotion (8 fl oz) due to confirmed mold contamination. The recall affects 120,319 bottles distributed nationwide.

    Product
    Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON, L3X 2S2, Made in Canada.
    Category
    Consumer Product
    Distribution
    Distributed nationwide