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.

8976–9000 of 27089

  • HighFDA (Devices)·Z-0131-2025·2024-10-23

    Rolling Walker Backrest May Disengage During Position Changes Creating Fall Risk

    Nova Ortho-Med is recalling 1,585 MONARCH ROLLATOR RED units because the backrest may disengage from its holder when users adjust from a slouched to upright position, creating a fall hazard.

    Product
    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2025·2024-10-23

    AVVIGO+ Multi-Modality Guidance System software defect causes incorrect grid display

    Boston Scientific recalled the AVVIGO+ Multi-Modality Guidance System because a software defect causes incorrect grid display in Live and Record modes, potentially affecting vessel imaging guidance for physicians using OptiCross 18 catheters.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT 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 whi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2025·2024-10-23

    Monarch Inflation Devices Recalled for Sterile Barrier Defects

    Merit Medical Systems is recalling approximately 6,565 Monarch Inflation Devices due to manufacturing defects that compromise the sterile barrier, potentially allowing device contamination.

    Product
    Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0049-2025·2024-10-23

    KINOVA Jaco assistive robot recalled for potential fire hazard

    Kinova Inc is recalling 949 KINOVA Jaco assistive robots due to a potential fire hazard that may occur if a damaged robot arm interacts with a wheelchair exhibiting electrical leakage.

    Product
    KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0042-2025·2024-10-23

    Seasoned Dried Whiting with Undeclared Wheat Allergen Recalled

    Lemonland Food Corp recalls Seasoned Dried Whiting due to undeclared wheat allergen. Consumers with wheat allergies should discard or return the product.

    Product
    Item FLD1004A, Seasoned Dried Whiting, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares: Dried Pollack, Starch Syrup, Soy Sauce, Red Pepper Powder, Sesame Seeds.
    Category
    Food
    Distribution
    1 state
  • 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-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 (Devices)·Z-0065-2025·2024-10-23

    basixTOUCH Inflation Device Recalled for Sterile Barrier Defect

    Merit Medical Systems is recalling the basixTOUCH Inflation Device (REF: IN8140/A) because devices may have a small hole in the sterile barrier, potentially exposing users to pathogens and pyrogens that could lead to infection.

    Product
    basixTOUCH Inflation Device, REF: IN8140/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2025·2024-10-23

    Boston Scientific AVVIGO+ Guidance System Recalled for Grid Overlay Display Error

    Boston Scientific is recalling AVVIGO+ systems due to a software anomaly that displays an incorrect grid overlay when connected to OptiCross 18 catheters, potentially leading to vessel imaging misinterpretation.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB 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 inc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0085-2025·2024-10-23

    Leica Cryostat Model CM1100 Recalled for Fire Risk from Flammable Freezing Sprays

    Leica Biosystems recalls its Cryostat Model CM1100 due to inadequate warnings about using flammable freezing sprays, which can ignite and cause serious injuries. The device labeling lacked required safety warnings prior to 2019.

    Product
    Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0087-2025·2024-10-23

    Leica Cryostat Model CM1850 Lacks Fire-Risk Warning for Flammable Sprays

    Leica Biosystems is recalling Cryostat Model CM1850 (322 units, US nationwide) due to missing warnings about fire hazard from flammable freezing sprays. The device's labeling prior to 2019 did not warn users that flammable sprays used in the chamber can ignite and cause serious injuries.

    Product
    Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0126-2025·2024-10-23

    Change Healthcare Cardiology Hemodynamic Software Calculation Error Recall

    Change Healthcare Cardiology Hemo software versions 14.1.1–15.1 may produce inaccurate hemodynamic calculations due to unit-of-measurement configuration errors, potentially leading to misdiagnosis and inappropriate patient treatment.

    Product
    Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0013-2025·2024-10-23

    First Aid Antiseptic Ointment Recalled for Mislabeled Inactive Ingredients

    Rugby Laboratories is recalling First Aid Antiseptic (Povidone-Iodine 10%) ointment because the product contains undeclared inactive ingredients not listed on the label.

    Product
    FIRST AID ANTISEPTIC — FIRST AID ANTISEPTIC (POVIDONE-IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0045-2025·2024-10-23

    Stewed Lotus Root Recalled for Undeclared Wheat and Fish Allergens

    Lemonland Food Corp is recalling Stewed Lotus Root for undeclared wheat and fish allergens. The product label does not declare wheat or fish (anchovy), which are present in the product.

    Product
    Item FLD1015A, Stewed Lotus Root, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares: Lotus Root, Salt, Soy Sauce, Corn Syrup
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0086-2025·2024-10-23

    Leica Biosystems Cryostat lacks warning for flammable freezing spray use

    Leica Biosystems Cryostat Model CM1510 S is recalled due to missing warning labels about flammable freezing sprays, which can ignite and cause serious injury. The device labeling lacked fire hazard warnings prior to 2019.

    Product
    Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0119-2025·2024-10-23

    Medline Heart CABG Cannulae Recalled Due to Incorrect Model Labeling

    Medline Industries is recalling 15 kits of MEDLINE HEART CABG DLP Vessel Cannulae due to incorrect model labeling discovered during manufacturing.

    Product
    MEDLINE HEART CABG CDS, REF CDS983376R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2025·2024-10-23

    Merit Medical basixSKY Inflation Device Recalled for Sterile Barrier Defect

    Merit Medical is recalling the basixSKY Inflation Device because a sterile barrier defect could expose users to harmful pathogens and bacteria, risking infection.

    Product
    basixSKY Inflation Device, REF: SKY1802
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0121-2025·2024-10-23

    Open Heart Surgical Kit Recalled for Incorrect Vessel Cannulae Model Labeling

    Medline Industries is recalling 123 kits of its Open Heart Pack after discovering that model 30001 vessel cannulae were incorrectly labeled as model 30000. This labeling error could lead to use of the wrong surgical instrument during open heart procedures.

    Product
    MEDLINE OPEN HEART PACK, REF DYNJ66216C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0129-2025·2024-10-23

    Rolling Walker Backrest May Disengage During Position Adjustment

    Nova Ortho-Med is recalling 1,886 MONARCH ROLLATOR BLUE rolling walkers due to a potential fall hazard. The backrest may disengage when users shift from a slouched to upright seated position.

    Product
    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0089-2025·2024-10-23

    Cryostat Model CM1950 Lacks Warning on Flammable Spray Use

    Leica Biosystems is recalling the Cryostat Model CM1950 due to missing warnings about using flammable freezing sprays in the device. Flammable sprays can ignite inside the chamber, potentially causing serious injuries.

    Product
    Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0050-2025·2024-10-23

    Stir Fried Dried Shrimp Recalled for Undeclared Wheat Allergen

    Lemonland Food Corp recalled stir-fried dried shrimp (Item FLD1971) distributed in Washington because wheat is not declared on the label, despite being present in the product.

    Product
    Item FLD1971, Stir Fried Dried Shrimp, distributed in plastic clamshell containers. Net wt. 0.165lb. The H-Mart label declares: Shrimp, Sesame Oil, Soy Sauce, Corn Syrup, Salt
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0056-2025·2024-10-23

    Olympus EVIS EXERA III Video System Recalled for Startup Failure

    Olympus is recalling 45 units of the EVIS EXERA III Video System Center (Model CV-190) that fail to start due to power supply defects. The endoscopy device was distributed nationwide.

    Product
    EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0110-2025·2024-10-23

    Boston Scientific AVVIGO+ Imaging System Grid Display Overlay Error

    Boston Scientific is recalling 5 units of its AVVIGO+ Guidance System due to a software error that displays an incorrect grid overlay when connected to OptiCross 18 Peripheral Imaging Catheters in Live or Record mode.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; 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
  • HighFDA (Devices)·Z-0099-2025·2024-10-23

    Boston Scientific imaging system software error in grid overlay display

    Boston Scientific AVVIGO+ imaging system has a software error causing incorrect grid overlay display in Live and Record modes, potentially affecting depth reference during vascular procedures. 2 units are recalled.

    Product
    Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includ
    Category
    Medical Device
    Distribution
    Distributed nationwide