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.

12176–12200 of 88183

  • HighFDA (Food)·F-1560-2024·2024-08-07

    Jeni's Ice Cream Sandwiches Recalled for Possible Listeria Contamination

    Jeni's Ice Cream Sandwich Chocolate Silk Pie ice cream is being recalled nationwide due to possible Listeria monocytogenes contamination. Affected products have best-by dates from July 2025 to May 2026.

    Product
    Jeni's Ice Cream Sandwich Chocolate Silk Pie Ice Cream 3.5 fl oz UPC 858241006882. Individually wrapped in plastic and packaged in cardboard box, 3 sandwiches per box. 8 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1596-2024·2024-08-07

    Marco Vanilla Chai Ice Cream recalled for possible Listeria contamination

    Marco Vanilla Chai Ice Cream 16 fl oz is being recalled due to possible contamination with Listeria monocytogenes. The affected products have best-by dates between 06/07/24 and 12/11/25.

    Product
    Marco Vanilla Chai Ice Cream 16 fl oz/1 pint, UPC 86000199286. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1555-2024·2024-08-07

    Cumberland Farms ice cream sandwich recalled for possible Listeria contamination

    Totally Cool, Inc. is recalling Cumberland Farms Farmhouse Premium Ice Cream Sandwiches (Rich Vanilla, 4 fl oz) due to possible Listeria monocytogenes contamination. Approximately 2,436 cases with best-by dates from 11/30/25 to 12/04/25 were distributed nationwide.

    Product
    Cumberland Farms Farmhouse Premium Ice Cream Sandwich, Rich Vanilla, 4 fl oz UPC 42704010046. Individually wrapped in plastic, 24 units per case.
    Category
    Food
    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 (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 (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 (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 (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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2415-2024·2024-07-31

    Electrosurgical Generators Olympus ESG-410 May Fail to Power On

    Olympus is recalling 86 ESG-410 Electrosurgical Generators because they may fail to power on during use, potentially delaying treatment or prolonging surgery.

    Product
    ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2429-2024·2024-07-31

    Abbott Infinity 5 Pulse Generator May Have Inaccurate Battery-Life Labels

    Abbott Infinity 5 implantable pulse generators have inaccurate end-of-service dates in labeling, which may result in loss of therapy. Approximately 5,900 units are affected and distributed worldwide.

    Product
    Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1491-2024·2024-07-31

    Universal Bakery Organic Sunrise Energy Bars recalled for undeclared gluten

    Universal Bakery Organic Sunrise Energy Bars labeled as gluten-free but found to contain gluten above FDA limits. The product poses a risk to consumers with celiac disease or gluten sensitivity.

    Product
    Universal Bakery Organic Sunrise Energy Bars 32 oz. and 10 oz. Gluten Free USDA Organic Made With: Rolled Oats, Dried Fruits, Flax Seeds, Quinoa, Coconut, Pumpkin Seeds, Chia Seeds + More Ingredients: Organic Rolled Oats, Organic Sunflower Oil, Organic Evaporated Cane Juice…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2426-2024·2024-07-31

    ABL800 FLEX Blood Gas Analyzers May Report Inaccurate pH Results

    Radiometer Medical ABL800 FLEX blood gas analyzers (models 393-800, 393-801) may report inaccurate pH results due to bacterial growth in calibration solution bottles. Approximately 27,127 units distributed worldwide are affected.

    Product
    ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2435-2024·2024-07-31

    Perfusor Space syringe pump recalled for Cardinal Health syringe incompatibility

    B Braun is recalling Perfusor Space syringe pumps because manufacturing changes to Cardinal Health Monoject syringes may cause incompatibility, resulting in dosing errors or delayed treatment.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pump, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1613-2024·2024-07-31

    Bakery Cookie Recalled for Undeclared Peanut Allergen

    Shweetz Bakery-To-Go cookies are being recalled due to undeclared peanuts. The recall affects 11,070 cookies distributed across Pennsylvania, Maryland, Ohio, Virginia, and West Virginia.

    Product
    Shweetz Bakery-To-Go brand Peanut Butter Brownie Cheezecake Mashup Cookie Net Wt. 3 oz (85g) UPC: 759465005029. Individually packaged in a clear film wrap. 45 units per case. Frozen storage, thawed for retail sale.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0617-2024·2024-07-31

    Venlafaxine Hydrochloride extended-release capsules recalled for failed dissolution specifications

    Zydus Pharmaceuticals (USA) Inc. is recalling Venlafaxine Hydrochloride Extended-Release Capsules USP 37.5mg due to failed dissolution specifications in lots M213175 and M213176. The recall affects 13,128 and 252 bottles distributed nationwide.

    Product
    VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
    Category
    Drug
    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-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…
    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 (Food)·F-1490-2024·2024-07-31

    Organic Aussie Bites recalled for undeclared gluten content

    Best Express Foods is recalling Universal Bakery Organic Aussie Bites due to undeclared gluten. Products labeled as gluten-free were found to contain gluten above regulatory limits.

    Product
    Universal Bakery Organic Aussie Bites, 30 oz clamshell container USDA Organic Certified Gluten Free Rolled Oats, Dried Apricots, Flax Seeds, Sunflower Seeds, Honey, Coconut, Quinoa, Chia Seeds + More! INGREDIENTS: Organic Rolled Oats, Organic Oat Flour, Organic Invert Cane…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2445-2024·2024-07-31

    LINK SymphoKnee Patella Sizing Template recalled due to incorrect markings

    LINK BIO CORP is recalling the LINK SymphoKnee Patella Sizing Template (Item Number 881-509/00, Lot C225066) because markings on two arms of the instrument were mixed up during manufacturing.

    Product
    LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
    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-2437-2024·2024-07-31

    Perfusor Space Syringe Pump Recalled for Monoject Syringe Incompatibility Risk

    B Braun's Perfusor Space infusion pump may be incompatible with Cardinal Health Monoject syringes affected by manufacturing changes, creating risks of overdose, underdose, and delayed therapy.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide