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.

10376–10400 of 27206

  • HighFDA (Food)·F-1553-2024·2024-08-07

    Yelloh! Cookies & Cream Ice Cream Sandwich Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling Yelloh! Cookies & Cream Ice Cream Sandwiches due to possible contamination with Listeria monocytogenes. The recall affects approximately 8400 cases distributed nationwide.

    Product
    Yelloh! Cookies & Cream Ice Cream Sandwich 24 fl oz UPC 810038685090. Individually wrapped in plastic. 6 sandwiches packaged in a cardboard box, 12 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1556-2024·2024-08-07

    Cumberland Farms Ice Cream Sandwich Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling Cumberland Farms Farmhouse Premium Ice Cream Sandwich in Marvelous Mint flavor due to possible Listeria monocytogenes contamination. Approximately 2,409 cases were distributed nationwide.

    Product
    Cumberland Farms Farmhouse Premium Ice Cream Sandwich, Marvelous Mint, 4 fl oz UPC 42704010046. Individually wrapped in plastic, 24 units per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1576-2024·2024-08-07

    Frozen dairy dessert recalled for possible Listeria monocytogenes contamination

    Totally Cool, Inc. is recalling The Frozen Farms Farm Crafted Orange Cream Frobert Frozen Dairy Dessert nationwide due to possible Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    The Frozen Farms Farm Crafted Orange Cream Frobert Frozen Dairy Dessert 16 fl oz/1 pint, UPC 850023398000. Packaged in paper containers, 8 containers per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1565-2024·2024-08-07

    Yelloh! Pecan Praline Sundae Cones recalled for possible Listeria contamination

    Yelloh! Pecan Praline Sundae Cones (4 fl oz) manufactured by Totally Cool, Inc. are being recalled due to possible contamination with Listeria monocytogenes.

    Product
    Yelloh! Pecan Praline Sundae Cones 4 fl oz UPC 810038684925. 12 cones wrapped in paper, packaged in cardboard box, 8 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1594-2024·2024-08-07

    Marco Turkish Mocha Ice Cream Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling Marco Turkish Mocha Ice Cream 16 fl oz due to possible Listeria monocytogenes contamination. Consumers should not consume affected products.

    Product
    Marco Turkish Mocha Ice Cream 16 fl oz/1 pint, UPC 860001992885. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2451-2024·2024-08-07

    Capio SLIM Suture Capturing Device may fail to catch sutures consistently

    Boston Scientific is recalling some lots of Capio SLIM Suture Capturing Devices because they may not consistently catch sutures during surgery, potentially requiring prolonged procedures or additional medical intervention.

    Product
    Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1559-2024·2024-08-07

    Ice Cream Sandwiches Recalled Due to Possible Listeria Contamination

    Totally Cool, Inc. is recalling Marco Sweets & Spices Dulce De Leche Ice Cream Sandwiches due to possible Listeria monocytogenes contamination. Approximately 1103 cases were distributed nationwide.

    Product
    Marco Sweets & Spices Dulce De Leche Ice Cream Sandwiches 3.8 fl oz UPC 860010682753. Individually wrapped in plastic. 3 sandwiches packaged in cardboard box, 8 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1567-2024·2024-08-07

    Vanilla Nut Sundae Cones Recalled for Possible Listeria Contamination

    Yelloh! Classic Vanilla Nut Sundae Cones are recalled nationwide due to possible contamination with Listeria monocytogenes. Consumers should dispose of or return affected packages.

    Product
    Yelloh! Classic Vanilla Nut Sundae Cones 4 fl oz UPC 810038684895. 24 cones wrapped in paper, packaged in cardboard box, 8 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2458-2024·2024-08-07

    BD Insyte Autoguard BC IV Catheter Recalled for Tubing Defect and Leakage

    Becton Dickinson has recalled certain BD Insyte Autoguard BC IV catheters due to potential holes in the catheter tubing that could cause leakage during insertion. The recall involves 26,400 units distributed in the United States.

    Product
    BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1546-2024·2024-08-07

    Friendly's Strawberry Krunch Ice Cream Cake recalled for possible Listeria contamination

    Friendly's Strawberry Krunch Ice Cream Cake is being recalled due to possible Listeria monocytogenes contamination. Approximately 86,540 cases distributed nationwide are affected.

    Product
    Friendly's Strawberry Krunch Ice Cream Cake 40 fl oz, UPC 29839413065. Packaged in cardboard box, 4 boxes per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1597-2024·2024-08-07

    Marco Peanut Butter Caramel Ice Cream Recalled Due to Listeria Risk

    Totally Cool, Inc. is recalling Marco Peanut Butter Caramel Ice Cream nationwide due to possible Listeria monocytogenes contamination. Consumers should not consume the product and should check their freezers for affected items.

    Product
    Marco Peanut Butter Caramel Ice Cream 16 fl oz/1 pint, UPC 860001992878. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2454-2024·2024-08-07

    SOFT-VU KUMPE Catheters Recalled for Mislabeled Inner Pouch

    Angiodynamics is recalling SOFT-VU KUMPE 5F X 65CM angiographic catheters (595 boxes nationwide) because inner pouch labels may show information for a different catheter model while shelf-box labels are correct.

    Product
    SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0621-2024·2024-08-07

    Prescription azelaic acid gel recalled for manufacturing process deviations

    Glenmark Pharmaceuticals recalls azelaic acid gel 15% nationwide due to manufacturing process deviations. Patients should consult their healthcare provider about their prescription.

    Product
    AZELAIC ACID — AZELAIC ACID (AZELAIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1519-2024·2024-08-07

    NaturesPlus Testosterone Supplement Recalled for Missing Ingredient and Incorrect Formulation

    Natural Organics is recalling NaturesPlus ULTRA T-MALE due to incorrect formulation: the product is missing the ingredient TongKat Ali and contains additional Rhodiola Rosea. No illnesses have been reported.

    Product
    NaturesPlus ULTRA T-MALE Maximum Strength Testosterone Boost for Men 60 Bi-layer Tablets
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1517-2024·2024-08-07

    Orzo (Vegan) Dried Recalled Due to Potential Mold Growth

    PASTAURORA LLC is recalling 27 packages of 10oz vegan dried orzo distributed in Washington due to potential mold growth contamination. Consumers should not consume the product.

    Product
    Orzo (vegan) Dried, net wt. 10oz in clear package with green/back printings on white label. UPC 810135110747.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1520-2024·2024-08-07

    NaturesPlus T-MALE Testosterone Support Supplement Recalled for Ingredient Mismatch

    NaturesPlus T-MALE liquid supplement is being recalled because the product is missing the key ingredient TongKat Ali and contains an additional ingredient, Rhodiola Rosea, that should not be present.

    Product
    NaturesPlus T-MALE Liquid Testosterone Support for Men 8 OZ Berry and 30 OZ Berry
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2453-2024·2024-08-07

    SOFT-VU KUMPE Diagnostic Catheter Recalled for Mislabeled Inner Pouch

    Angiodynamics recalls SOFT-VU KUMPE diagnostic catheters because inner pouch labels may show incorrect catheter length information, while the outer box label is accurate. 519 boxes distributed nationwide.

    Product
    SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0623-2024·2024-08-07

    Ciprofloxacin Ophthalmic Solution Recalled Due to Defective Container

    FDC Limited is recalling 66,528 bottles of Ciprofloxacin ophthalmic solution USP 0.3% due to a manufacturing defect in the container cap that prevents access to the medication. All affected bottles were distributed nationwide.

    Product
    CIPROFLOXACIN — CIPROFLOXACIN (CIPROFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2409-2024·2024-07-31

    NIM Vital Nerve Monitoring Systems Recalled for False Negative Risk

    Medtronic Xomed is recalling NIM Vital Nerve Monitoring systems because they may fail to detect nerve damage or dysfunction. Approximately 7,804 units were distributed worldwide.

    Product
    NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2432-2024·2024-07-31

    Abbott Infinity 7 Implantable Pulse Generators Recalled for Potentially Shortened Service Life

    Abbott is recalling 1198 Infinity 7 Implantable Pulse Generators due to potentially incorrect service life indicators and end-of-service dates in product labeling, which could result in loss of therapy.

    Product
    Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2441-2024·2024-07-31

    Sensis Vibe medical diagnostic system software crashes during documentation events

    A software issue in certain Siemens Sensis Vibe diagnostic systems may cause the application to crash when documentation features are used during clinical reporting events.

    Product
    Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2024·2024-07-31

    Sensis Vibe Cardiac Imaging System Software May Crash During Documentation

    Siemens' Sensis Vibe cardiac imaging system software may crash when documentation functionality is used during diagnostic event recording. Two affected systems have been recalled nationwide.

    Product
    Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as intervention
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2434-2024·2024-07-31

    Perfusor Space Syringe Pump Recalled Due to Monoject Syringe Incompatibility

    B Braun Medical's Perfusor Space Syringe Pump may not properly recognize Cardinal Health Monoject syringes due to manufacturing changes, risking medication overdose, underdose, or therapy delays.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product Description: Perfusor Space Syringe Pump, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2433-2024·2024-07-31

    Infusion Pump Syringe Compatibility Issue May Cause Overdose or Underdose

    B Braun is recalling Perfusor Space infusion pumps due to syringe compatibility issues with Cardinal Health Monoject syringes. The incompatibility may cause overdose, underdose, therapy delays, and alarm failures.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2438-2024·2024-07-31

    Sensis Vibe diagnostic systems software crash during event documentation

    Siemens Sensis Vibe diagnostic systems may crash when using documentation features during once-per-study event reporting. Three systems are affected; no injuries reported.

    Product
    Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as wel
    Category
    Medical Device
    Distribution
    Distributed nationwide