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.

10351–10375 of 27089

  • HighFDA (Devices)·Z-2397-2024·2024-07-24

    IV Infusion Pump Set Valve May Cause Dangerous Medication Backflow

    B. Braun's Infusomat pump sets may have faulty backcheck valves causing medication to backflow between IV bags, risking reduced medication delivery and adverse reactions. All units distributed worldwide after August 2023 are affected.

    Product
    Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2377-2024·2024-07-24

    IV Infusion Set Backcheck Valve Malfunction May Cause Medication Loss

    B. Braun is recalling OUTLOOK IV Sets due to potential backcheck valve malfunction that could allow medication backflow and loss. The defect may result in adverse drug reactions or medication loss.

    Product
    OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1505-2024·2024-07-24

    Canned Coffee Beverages Recalled for Potential Under-Processing Risk

    Snapchill, LLC is recalling approximately 549,146 cans of Coffee Hound and Helm brand maple latte beverages due to potential under-processing during manufacturing.

    Product
    Coffee + Non-Dairy Creamer + Maple Syrup Canned Beverage packaged under the following brands and sizes: 1. Coffee Hound Coffee Co Maple Leaf Latte, 12 oz. UPC 7 83970-58496 0. 2. Helm Coffee Nitro Maple Latte, 12 oz. UPC 8 10149-37065 6.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0597-2024·2024-07-24

    FDA Recalls Nitrofurantoin Capsules Due to Failed Dissolution Specifications

    Sun Pharmaceutical recalls Nitrofurantoin Capsules (100 mg) due to failed dissolution, affecting medication effectiveness. The recall involves 5,752 bottles nationwide in lots 231067 and 231069.

    Product
    NITROFURANTION — NITROFURANTION (NITROFURANTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2402-2024·2024-07-24

    Outlook IV Infusion Pump Set Recalled Due to Backcheck Valve Malfunction Risk

    B. Braun is recalling Outlook IV pump sets due to potential backcheck valve malfunction that could allow medication backflow and prevent proper priming, posing a risk of adverse drug reactions and medication loss.

    Product
    Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490361
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2401-2024·2024-07-24

    Infusomat UNIV 60 IV Infusion Pump Set Recalled for Valve Malfunction Risk

    B. Braun is recalling Infusomat UNIV 60 IV infusion pump sets due to a backcheck valve defect that could cause medication backflow between IV containers and prevent priming, potentially resulting in adverse drug reactions or medication loss.

    Product
    Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number : 490104
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2412-2024·2024-07-24

    Surgical Image Guidance Software May Cause Incorrect Toric IOL Axis Placement

    Surgical image guidance software in NGENUITY 3D systems may miscalculate lens axis placement during eye rotation, potentially causing astigmatic error and decreased visual acuity.

    Product
    Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2393-2024·2024-07-24

    IV Infusion Pump Set Backcheck Valve Malfunction Recall

    B. Braun Medical recalls Infusomat UNIV. 15 DROP PUMP SET due to backcheck valve malfunction that could cause medication backflow and loss of medication, resulting in adverse drug reactions.

    Product
    Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363433
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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 wit
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2379-2024·2024-07-24

    Infusion Pump Sets Recalled for Potential Backflow of Medication

    B. Braun is recalling Infusomat UNIV. 15 IV pump sets due to a backcheck valve malfunction that could divert medication between containers and prevent proper priming.

    Product
    Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 362033
    Category
    Medical Device
    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-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-1508-2024·2024-07-24

    FDA Recalls Coffee Beverages for Potential Under-Processing Nationwide

    Snapchill, LLC is recalling Wild Goose Coffee Roasters Draft Latte canned beverages due to potential under-processing. The affected cans may not have been adequately processed to kill pathogens, posing a food safety risk.

    Product
    Coffee + Non-Dairy Creamer + Agave Nectar Canned Beverage packaged under the following brands and sizes: 1. Wild Goose Coffee Roasters Draft Latte, 12 oz. UPC 8 10149-37094 6.
    Category
    Food
    Distribution
    Distributed nationwide
  • 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 (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-2387-2024·2024-07-24

    B. Braun Infusomat SPACE IV Set Backcheck Valve Malfunction Recall

    B. Braun Medical is recalling 68,205 Infusomat SPACE IV Sets due to a potential backcheck valve malfunction that could allow medication backflow between IV containers.

    Product
    Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363420
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0602-2024·2024-07-24

    Cardura XL Tablets Recalled for Failed Impurities and Degradation Specifications

    Viatris Inc is recalling Cardura XL (doxazosin) 4mg tablets due to failed impurities and degradation specifications. The recall affects 12,691 bottles distributed nationwide.

    Product
    Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10
    Category
    Drug
    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-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 (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
    0 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-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 (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 (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