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.

10851–10875 of 88183

  • HighFDA (Devices)·Z-0088-2025·2024-10-23

    Leica Cryostat Model CM1900 Lacks Warning on Flammable Sprays

    Leica Biosystems is recalling the Cryostat Model CM1900 because its labeling lacks a warning about using flammable freezing sprays in the chamber. The sprays can ignite, creating a serious fire and burn hazard.

    Product
    Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0073-2025·2024-10-23

    Merit Medical StabiliT TOUCH Syringe Sterile Barrier Defect Recall

    Merit Medical Systems is recalling 202 StabiliT TOUCH Syringes with potential small holes in the sterile barrier. Affected devices may expose users to pathogens and pyrogens, which could cause infection.

    Product
    StabiliT TOUCH Syringe, REF: IN8VCF/B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0039-2025·2024-10-23

    Lemonland Food Corp Recalls Perilla Leaves in Soybean Paste for Undeclared Wheat and Sesame

    Lemonland Food Corp recalls Item FLD1000A Perilla Leaves in Soybean Paste distributed in Washington. The product label omits wheat and sesame seeds, which are present in the product.

    Product
    Item FLD1000A, Perilla Leaves in Soybean Paste, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares Perilla Leaves, Soybean Paste.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0125-2025·2024-10-23

    Cortera spinal fixation system screws recalled due to manufacturing specification concerns

    XTANT Medical is recalling 330 Cortera spinal fixation system screws marked 'DNI' because they may not have been manufactured to specification and could lack adequate strength if implanted.

    Product
    Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2025·2024-10-23

    BlueFIRE Inflation Device Recalled for Sterile Barrier Defect Risk

    BlueFIRE Inflation Devices may have a small hole in the sterile barrier, potentially exposing patients to pathogens that could cause infection. Contact your healthcare provider if you received this device.

    Product
    BlueFIRE Inflation Device, REF: IN10140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0115-2025·2024-10-23

    Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly

    Boston Scientific is recalling 4 units of the AVVIGO+ Multi-Modality Guidance System because a software error displays the wrong grid overlay during Live or Record mode.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0107-2025·2024-10-23

    Boston Scientific AVVIGO+ Guidance System Grid Mark Overlay Defect

    Boston Scientific is recalling the AVVIGO+ Multi-Modality Guidance System due to a software defect that displays an incorrect 9-grid mark overlay instead of the correct 15-grid mark overlay when used with OptiCross 18 Peripheral Imaging Catheters in Live or Record mode.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0027-2025·2024-10-23

    Rum Nut Ice Cream Recalled Due to Undeclared Yellow 5 and Yellow 6

    Today's Frozen Desserts recalls Rum Nut Ice Cream distributed in Florida due to undeclared Yellow 5 and Yellow 6 food colorants. The recall affects 1,363 units with expiration dates from June 13 to September 13, 2025.

    Product
    Rum Nut Ice Cream, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0112-2025·2024-10-23

    Medical imaging system software defect causes incorrect grid overlay display

    Boston Scientific recalled the AVVIGO+ imaging guidance system due to a software defect that displays a 9-grid overlay instead of the correct 15-grid overlay when connected to OptiCross 18 catheters in Live or Record mode.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0033-2025·2024-10-23

    Great Value Cherry Mixed Fruit Recalled for Undeclared Food Colorant

    Walmart is recalling Great Value Cherry Mixed Fruit cups nationwide because FD&C Red No 3 was not declared as an ingredient on the label.

    Product
    Great Value Cherry Mixed Fruit, 4 oz, 4 Count and 12 count plastic cups sealed with clear film.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0011-2025·2024-10-23

    Prescription Dapsone Gel 7.5% Recalled Due to Crystallization

    Viona Pharmaceuticals has voluntarily recalled 2,544 pumps of Dapsone Gel 7.5% (Lot #T400512) due to crystallization. The affected product was distributed in New York.

    Product
    DAPSONE — DAPSONE (DAPSONE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0026-2025·2024-10-23

    Rum Raisin Ice Cream Recalled for Undeclared Yellow 5 and Yellow 6

    Today's Frozen Desserts has recalled Rum Raisin ice cream distributed in Florida due to undeclared Yellow 5 and Yellow 6 food colorants. Approximately 1,363 units are affected.

    Product
    Rum Raisin Ice Cream, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0032-2025·2024-10-23

    Great Value Mixed Fruits Variety Pack Recalled for Undeclared Food Dye

    Walmart is recalling Great Value Diced Peaches, Mandarin Segments, & Cherry Mixed Fruits Variety Pack because FD&C Red No. 3 was not declared on the label. The recall affects 511,164 units distributed nationwide.

    Product
    Great Value Diced Peaches, Mandarin Segments, & Cherry Mixed Fruits Variety Pack, 4 oz, 12 Pack
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0120-2025·2024-10-23

    Medline Heart Overhead Table Pack recalled for incorrect model labeling

    Medline Industries recalls Heart Overhead Table Packs due to incorrect labeling. Some kits were marked as model 30000 when they should be model 30001.

    Product
    MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0093-2025·2024-10-23

    Beckman Coulter Urine Chemistry Controls May Produce False Positive Results

    Beckman Coulter IRISPEC urine chemistry control materials may intermittently fail to detect negative glucose, producing false positive control results that could delay patient test reporting.

    Product
    Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0029-2025·2024-10-23

    Premium Grapenut Frozen Dessert Recalled for Undeclared Food Coloring

    Today's Frozen Desserts is recalling Premium Grapenut frozen dessert products sold in Florida due to undeclared Yellow 5 and Yellow 6 food coloring additives not listed on product labels.

    Product
    Premium Grapenut, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0098-2025·2024-10-23

    Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly

    Boston Scientific is recalling 15 units of the AVVIGO+ Multi-Modality Guidance System because a software anomaly causes an incorrect grid overlay to display during Live or Record mode.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0116-2025·2024-10-23

    Boston Scientific Recalls AVVIGO+ Guidance Systems Due to Software Display Error

    Boston Scientific is recalling 40 AVVIGO+ Multi-Modality Guidance Systems because a software anomaly causes an incorrect grid overlay to display during Live or Record mode when used with specific catheters.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0102-2025·2024-10-23

    Boston Scientific AVVIGO+ guidance system recalled for grid overlay display error

    Boston Scientific's AVVIGO+ guidance system is recalled because a software glitch causes an incorrect grid overlay display when used with an OptiCross 18 catheter. The correct overlay appears in Review mode, and no patient injuries have been reported.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0103-2025·2024-10-23

    Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly

    Boston Scientific is recalling 14 units of the AVVIGO+ Multi-Modality Guidance System due to a software anomaly that displays an incorrect grid overlay during Live or Record mode.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0051-2025·2024-10-23

    El Gallo Azul Processed Cheese Recalled for Non-English Labeling

    El Gallo Azul Cock Brand Queso Procesado processed cheese in 300g metal cans is recalled for non-English labeling. The product was distributed in Oregon.

    Product
    El Gallo Azul Cock Brand Queso Procesado/Processed Cheese 300g packaged in a metal can
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0109-2025·2024-10-23

    Boston Scientific AVVIGO+ Medical Device Grid Overlay Display Error

    Boston Scientific recalls 161 AVVIGO+ Multi-Modality Guidance Systems due to a software error causing an incorrect grid overlay display in Live and Record modes. The error affects measurement reference accuracy during intravascular imaging procedures.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0123-2025·2024-10-23

    Medical Device Kit Incorrectly Labeled With Wrong Model Number

    Medline Industries recalls MEDLINE KIT CV I II vessel cannulae kits because product for model 30001 was incorrectly labeled as model 30000 during manufacturing.

    Product
    MEDLINE KIT CV I II, REF DYNJ906071B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0124-2025·2024-10-23

    Medline Open Heart Kits Recalled Due to Incorrect Cannula Labeling

    Medline Industries is recalling 22 Open Heart NIMC Kits because they contain Medtronic DLP Vessel Cannulae that were incorrectly labeled during manufacturing.

    Product
    MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0040-2025·2024-10-23

    Seasoned Sesame and Perilla Leaves Recalled for Undeclared Monosodium Glutamate

    Lemonland Food Corp is recalling Seasoned Sesame Leaves and Seasoned Perilla Leaves due to undeclared monosodium glutamate (MSG). The product was distributed in Washington.

    Product
    Item FLD1000AA, Seasoned Sesame Leaves or Seasoned Perilla Leaves, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares: Sesame Leaves, Red Pepper Powder, Malt Syrup, Soybean, Wheat, Anchovy, Salt, Carrots, Leeks, Garlic, Onion.
    Category
    Food
    Distribution
    1 state