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.

12826–12850 of 22165

  • HighFDA (Drugs)·D-0272-2024·2024-01-31

    Zolpidem Tartrate Extended-Release Tablets Recalled for Manufacturing Contamination

    SUN PHARMACEUTICAL INDUSTRIES is recalling 14,568 bottles of Zolpidem Tartrate Extended-Release 12.5mg tablets nationwide due to microbial contamination discovered in manufacturing equipment. Affected lot: DNE0893A (expires 07/31/2026).

    Product
    ZOLPIDEM TARTRATE — ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0794-2024·2024-01-31

    Bard Nasogastric Sump Tubes recalled due to inadequate suction and drainage

    C.R. Bard is recalling 37,059 units of Bard Nasogastric Sump Tubes with ENFit due to user reports of inadequate suction, decompression, and drainage during use.

    Product
    Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180
    Category
    Medical Device
    Distribution
    0 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 (Devices)·Z-0779-2024·2024-01-31

    Medtronic Cobalt XT DR MRI cardioverter defibrillator battery testing defect

    Medtronic is recalling Cobalt XT DR MRI implantable cardioverter defibrillators due to a manufacturing defect in the battery testing process. Some batteries may have bypassed required validation.

    Product
    Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0795-2024·2024-01-31

    Bard PreVent Anti-Reflux Filter with ENFit Recall for Reduced Suction

    C.R. Bard is recalling Bard PreVent Anti-Reflux Filters with ENFit connectors due to user reports of inadequate or reduced suction, decompression, and drainage during use.

    Product
    Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0784-2024·2024-01-31

    Beckman Coulter DxU Analyzers Recalled for Potential Rust-Related Diagnostic Errors

    Beckman Coulter is recalling DxU 850m/840m Microscopy Analyzers (254 units) due to potential rust in the cannula component, which may cause erroneous test results. The recall affects units distributed in the US and multiple international locations.

    Product
    Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0796-2024·2024-01-31

    Bard Nasogastric Sump Tubes recalled for inadequate suction and drainage

    C.R. Bard is recalling Bard Nasogastric Sump Tubes due to user complaints of inadequate suction and drainage during use. Approximately 6,600 units were affected.

    Product
    Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100
    Category
    Medical Device
    Distribution
    0 states
  • 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-0785-2024·2024-01-31

    Beckman Coulter iQ200 Analyzers Recalled for Potential Rust and Diagnostic Errors

    Beckman Coulter is recalling 112 units of iQ200 Series Urine Microscopy Analyzers distributed globally. The cannula in the Flowcell and Rinse Waste Well Assembly may rust, potentially causing erroneous diagnostic results.

    Product
    iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0795-2024·2024-01-31

    DeIorio Foods Pizza Dough Recalled for Conveyor Belt Piece Contamination

    DeIorio Foods has recalled frozen pizza dough sheets that may contain conveyor belt pieces. The recall affects products distributed in CA, NC, and PA with best-use dates of 02/16/2024.

    Product
    DeIorio Foods, Inc. brand Cafe Pizza Dough Sheet; Keep Frozen
    Category
    Food
    Distribution
    3 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
    0 states
  • HighFDA (Devices)·Z-0798-2024·2024-01-31

    Bard Nasogastric Sump Tubes recalled for reduced suction and drainage

    C.R. Bard has recalled certain nasogastric sump tubes due to user reports of inadequate suction and drainage. The affected devices may fail to properly decompress the stomach.

    Product
    Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0793-2024·2024-01-31

    C.R. Bard Nasogastric Sump Tubes recalled for inadequate drainage and suction

    C.R. Bard is recalling Bard Nasogastric Sump Tubes with ENFit connectors due to user reports of inadequate suction and drainage. The recall affects 16,564 units distributed in the United States.

    Product
    Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160
    Category
    Medical Device
    Distribution
    0 states
  • 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 (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 (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
    0 states
  • HighFDA (Devices)·Z-0790-2024·2024-01-31

    Bard Nasogastric Sump Tube with ENFit Recalled for Reduced Suction and Drainage

    C.R. Bard is recalling 3,400 units of Bard Nasogastric Sump Tube with ENFit due to reports of inadequate suction, decompression, and drainage during use affecting patients requiring nasogastric care.

    Product
    Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0791-2024·2024-01-31

    Bard Nasogastric Sump Tubes recalled for inadequate suction and drainage

    C.R. Bard is recalling Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction and drainage during use. The defect may prevent proper gastric decompression.

    Product
    Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0803-2024·2024-01-31

    Bard Nasogastric Sump Tube Recalled Due to Reduced Suction and Drainage

    C.R. Bard is recalling 3,650 units of Bard Nasogastric Sump Tubes with ENFit connectors due to user complaints of inadequate suction, decompression, and drainage during use. The issue could affect proper tube function in clinical settings.

    Product
    Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0804-2024·2024-01-31

    Bard Nasogastric Sump Tube Recalled for Inadequate Suction and Drainage

    C.R. Bard Inc is recalling 8,010 units of Bard Nasogastric Sump Tubes with ENFit connectors due to reports of inadequate or reduced suction, decompression, and drainage.

    Product
    Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160
    Category
    Medical Device
    Distribution
    0 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 (Food)·F-0794-2024·2024-01-31

    Frozen cheese croquettes recalled for possible Listeria monocytogenes contamination

    Lidl US is recalling Duc De Coeur Camembert Cheese Croquettes due to possible contamination with Listeria monocytogenes. No illnesses have been reported.

    Product
    Duc De Coeur Camembert Cheese Croquettes Frozen NET WT 9 OZ (256g) UPC 2023 8391 Packaged in a cardboard cartons.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-0813-2024·2024-01-31

    Ultrasound system recalled due to measurement error in Dual Live Compare feature

    B-K Medical A/S is recalling bkActiv Ultrasound System 2300 models because a measurement error could occur in the Dual Live Compare feature, potentially affecting diagnostic accuracy.

    Product
    bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
    Category
    Medical Device
    Distribution
    Distributed nationwide