The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

10301–10325 of 53042

  • HighFDA (Devices)·Z-0797-2024·2024-01-31

    Bard Nasogastric Sump Tubes Recalled for Reduced Suction and Drainage

    C.R. Bard is recalling 26,100 nasogastric sump tubes due to user complaints of inadequate suction and reduced drainage. The malfunction could prevent proper stomach decompression.

    Product
    Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0777-2024·2024-01-31

    Ultrasound Gel Sterility Cannot Be Guaranteed — FDA Recall

    Turkuaz Saglik Hizmetleri is recalling over 4.9 million units of sterile ultrasound gel (REF 126590) because manufacturer cannot guarantee its sterility. Affected products in Illinois and Hong Kong should not be used.

    Product
    REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0782-2024·2024-01-31

    Hologic PANTHER FUSION System Recalled for Potential False Positive Flu B Results

    Hologic is recalling PANTHER FUSION nucleic acid testing systems due to the potential for false positive influenza B test results when a sample is also positive for SARS-CoV-2.

    Product
    PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0262-2024·2024-01-31

    FDA Recalls Fosaprepitant Injection Due to Sterility Assurance Failure

    BE Pharmaceuticals recalls Fosaprepitant for Injection nationwide due to failed aseptic process validation. The 22,176 vials from lot #13D012AA may lack sterility assurance.

    Product
    FOSAPREPITANT — FOSAPREPITANT (FOSAPREPITANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0787-2024·2024-01-31

    iQ Waste Well Adapter Recalled for Rust in Cannula Component

    Beckman Coulter recalls the iQ Waste Well Adapter due to rust in the cannula that may generate erroneous test results in laboratory diagnostic equipment.

    Product
    iQ Waste Well Adapter, Part Number: 700-3393
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0273-2024·2024-01-31

    Fexofenadine Hydrochloride Antihistamine Tablets Recalled for Microbial Contamination

    Sun Pharmaceutical is recalling Fexofenadine Hydrochloride 180mg tablets due to microbial contamination discovered in manufacturing equipment. Approximately 54,504 bottles distributed nationwide are affected by this Class II recall.

    Product
    FEXOFENADINE HYDROCHLORIDE — FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0806-2024·2024-01-31

    Bard Suction Connector with ENFit Recalled for Inadequate Drainage

    C.R. Bard is recalling 133,610 Bard Suction Connectors with ENFit (model EN0066000) due to user complaints of inadequate suction and drainage. No injuries have been reported.

    Product
    Bard¿ Suction Connector with ENFit, REF EN0066000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0801-2024·2024-01-31

    Nasogastric Valve Recalled for Reduced Suction and Drainage

    C.R. Bard Inc. is recalling approximately 187,550 Bard Lopez Valve units due to user complaints of inadequate suction, decompression, and drainage during use. No illnesses or injuries have been reported.

    Product
    Bard¿ Lopez Valve¿ with ENFit, REF EN0056000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0776-2024·2024-01-31

    Frozen Vegan Pizza Recalled for Undeclared Milk Allergen

    365 Whole Foods Vegan Ultimate Veggie pizza (13.7 oz, UPC 0 99482-51870 7) is recalled for undeclared milk. Consumers with milk allergies should not consume this product. It was distributed to GA, PA, TX, and WA.

    Product
    365 Whole Foods Vegan Ultimate Veggie, Thin Cust Pizza. Item # 999209512 Topped with Vegan Mozzarella-Style Cheese, Green and Red Bell Peppers, Mushrooms, Black Olives and Red Onions. Net Wt 13.7 oz (388g) UPC 0 99482-51870 7. Keep Frozen. Distributed by Whole Foods Market,
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0793-2024·2024-01-31

    Vermont Village Apple Sauce Recalled for Elevated Patulin Contamination

    Stonewall Kitchen is recalling Vermont Village Unsweetened Apple Sauce (24oz) because the product contains elevated levels of patulin, a mycotoxin. The recall affects 9,027 units distributed across 22 U.S. states.

    Product
    Vermont Village Unsweetened Apple Sauce (24oz)
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-0791-2024·2024-01-31

    Chocoflan Dessert Recalled for Undeclared Wheat and Other Allergens

    Lara's Bakery 3 LLC is recalling Chocoflan dessert products for undeclared wheat and potential cross-contamination with sesame, coconut, soy, milk, and eggs. Consumers with allergies should not consume this product.

    Product
    Chocoflan (Chocolate Custard Dessert), Net Wt 1/2 lb, packaged in plastic clamshell.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0778-2024·2024-01-31

    Accure Laser System recalled due to spot tracking misalignment risk

    Accure Acne, Inc. is recalling the Accure Laser System Model PFMS00004 because its spot tracking system may misalign, potentially delivering higher-than-expected laser energy that could cause blistering.

    Product
    Accure Laser System, Model: PFMS00004
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-0779-2024·2024-01-31

    Odds & Ends Organic Chocolate Fruit & Nut Mix Recalled for Foreign Material

    United Natural Trading Inc. is recalling Odds & Ends Organic Chocolate Fruit & Nut Mix due to the presence of stems and vegetation. The product was distributed to Maryland, Oregon, and Massachusetts.

    Product
    Odds & Ends Organic Chocolate Fruit & Nut Mix 14oz. plastic resealable bags . 12/14oz bags per case.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0789-2024·2024-01-31

    Snapshot NIR Tissue Oxygenation System Touchscreens May Be Unresponsive

    Kent Imaging's Snapshot NIR tissue oxygenation measurement system touchscreens may become unresponsive, preventing users from viewing diagnostic oxygenation images. Fifty-seven units have been distributed across multiple US states and Malaysia.

    Product
    Snapshot NIR, REF: KD204
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0792-2024·2024-01-31

    Bard Nasogastric Sump Tubes recalled for reduced suction and drainage

    C.R. Bard is recalling 17,250 Bard Nasogastric Sump Tubes with ENFit connectors due to user complaints of inadequate or reduced suction, decompression, and drainage during use. These tubes may not function properly for their intended medical purpose.

    Product
    Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0800-2024·2024-01-31

    Bard Nasogastric Sump Tube Recalled for Reduced Suction and Drainage

    C.R. Bard is recalling Bard Nasogastric Sump Tubes due to reports of inadequate or reduced suction, decompression, and drainage during use. The recall affects 57,159 units distributed in the United States.

    Product
    Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0802-2024·2024-01-31

    Bard Nasogastric Sump Tube Recalled for Inadequate Drainage

    C.R. Bard is recalling 3,360 units of Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction and drainage during use.

    Product
    Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long, REF EN0056120
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0787-2024·2024-01-31

    RTB Mixed Danish Variety Recalled for Undeclared Soy Lecithin

    Lecoq Cuisine Corporation is recalling RTB Mixed Danish Variety pastries due to undeclared soy lecithin. The recall affects 7,620 units distributed across 26 states.

    Product
    RTB MIXED DANISH Variety
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-0786-2024·2024-01-31

    R&B Chocolate Chips Croissant Twist contains undeclared soy lecithin

    Lecoq Cuisine Corporation is recalling R&B Chocolate Chips Croissant Twist because the product contains undeclared soy lecithin. Consumers with soy allergies may be at risk if they consume this product.

    Product
    R&B Chocolate Chips Croissant Twist
    Category
    Food
    Distribution
    27 states
  • HighNHTSA·24V054000·2024-01-30

    Travel trailer cooktop control boards can overheat and cause fire

    Winnebago is recalling certain 2022-2023 Micro Minnie, Micro Minnie FLX, Hike 200 and Minnie travel trailers because the LED backlight circuit board in the cooktop range may fail and overheat.

    Product
    WINNEBAGO — WINNEBAGO MICRO MINNIE, MINNIE, MICRO MINNIE FLX, HIKE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V049000·2024-01-26

    Tiffin Convoy solar panel brackets may crack and release the panel

    Tiffin is recalling certain 2023-2024 Convoy and GH-1 motorhomes because the bracket securing the roof solar panel may crack and break, allowing the panel to detach. 67 units affected.

    Product
    TIFFIN — TIFFIN CONVOY, GH1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24E005000·2024-01-26

    Renogy Recalls 12V, 24V, and 48V Battery Packs Due to Fire Risk

    Renogy is recalling specific battery packs because relay contactors may become stuck, increasing the risk of fire during charging.

    Product
    ELECTRICAL SYSTEM:12V/24V/48V BATTERY recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide