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.

9376–9400 of 88183

  • ModerateFDA (Devices)·Z-0979-2025·2025-01-29

    CODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions

    Integra LifeSciences is recalling 46 units of the CODMAN CERTAS Plus Programmable Valve due to incorrect product descriptions on internal and external labels. The affected devices were distributed nationwide across the U.S. and internationally.

    Product
    CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0408-2025·2025-01-29

    River Valley Ranch Spinach Artichoke Dip Mix Recalled for Underprocessing

    River Valley Ranch & Kitchens Spinach Artichoke Dip Mix (224 jars, Wisconsin) has been recalled due to underprocessing. Affected batches are 40124113001, 40124113002, and 40124113003.

    Product
    River Valley Ranch & Kitchens Spinach Artichoke Dip Mix. net wt. 16 oz. (453g). UPC 6 92016-40021 1. Keep Refrigerated After Opening. 39900 60th Street, Burlington, WI 53105.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0205-2025·2025-01-29

    Kissable Diabetics Foot Cream recalled nationwide for inadequate release testing

    Brands International Corporation is recalling Kissable Diabetics Foot Cream nationwide due to lack of adequate release testing during manufacturing. The FDA has classified this as a Class II recall.

    Product
    Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0970-2025·2025-01-29

    Otological Ventilation Tube Recalled Due to Lack of FDA Clearance

    Adept Medical Ltd is recalling otological ventilation tubes distributed without FDA 510(k) clearance. The recall affects 4,080 units distributed in the US and internationally.

    Product
    Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0975-2025·2025-01-29

    BD Pyxis Med ES Medication Cabinet Drawer and Door Failure Recall

    CareFusion recalls the BD Pyxis Med ES Auxiliary medication cabinet due to drawer and door failures that may delay access to medications. Three failure modes identified: door latch failure, cable ribbon damage, and magnet falling out.

    Product
    BD Pyxis Med ES Auxiliary (AUX), REF 343
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0980-2025·2025-01-29

    Stryker Surgical Burs Recalled Due to Package Label Mismatch

    Stryker Corporation is recalling surgical burs that may be packaged with incorrect labels, causing a mismatch between the device model inside and the label. Approximately 491 affected devices were distributed worldwide.

    Product
    The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology, orthopedic, and general…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0978-2025·2025-01-29

    Integra implantable hydrocephalus valve recalled for incorrect product description on labels

    Integra LifeSciences is recalling CODMAN CERTAS Plus Programmable Valves (Model 828810PL) due to incorrect product descriptions on internal and external labels. The mislabeling affects 170 units distributed across the US and several international locations.

    Product
    CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0967-2025·2025-01-29

    Otological Ventilation Tube Recalled Due to Lack of Regulatory Clearance

    Adept Medical Ltd is recalling otological ventilation tubes distributed without FDA 510(k) clearance. The recall affects approximately 2,190 units in the US.

    Product
    Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0984-2025·2025-01-29

    Medtronic Pediatric Arterial Cannulae Recalled for Incorrect Labeling

    Medtronic is recalling 745 DLP Pediatric Arterial Cannulae (Models 77008 and 77014) due to incorrect labeling affecting seven manufactured lots distributed nationwide and worldwide.

    Product
    DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0405-2025·2025-01-29

    Mr. Bing Sriracha Chili Sauce Recalled for Possible Spoilage

    Mr. Bing brand Sriracha Chili Sauce in 9 oz and 18 oz bottles is being recalled because it may contain spoilage organisms. Affected consumers should not use the product.

    Product
    Mr. Bing brand Sriracha Chili Sauce; 9 oz and 18 oz, in clear PET bottle with green cap; UPC 850044819072 and UPC 850044819058
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0968-2025·2025-01-29

    Otological Ventilation Tubes recalled due to lack of FDA 510(k) clearance

    Adept Medical Ltd is recalling 310 units of Otological Ventilation Tubes (Product Code NZ3312-2) distributed in the US and internationally due to lack of FDA 510(k) regulatory clearance. The devices were distributed without required FDA pre-market approval.

    Product
    Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0964-2025·2025-01-29

    Otological Ventilation Tubes Distributed Without FDA 510(k) Clearance

    Adept Medical Ltd is recalling 2,010 units of T-Tube 6mm Double Silicone otological ventilation tubes distributed without required FDA 510(k) clearance. The recall affects 630 US units and 1,380 international units.

    Product
    Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0965-2025·2025-01-29

    Otological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance

    Adept Medical Ltd is recalling 2,610 T-Tube 9mm otological ventilation tubes distributed without required FDA premarket 510(k) clearance. The affected silicone tubes were sold in the US and internationally.

    Product
    Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0208-2025·2025-01-29

    Venlafaxine Extended-Release Tablets Recalled for Missing Tablet Identification

    Appco Pharma LLC is recalling Venlafaxine Extended-Release Tablets, 150mg, due to missing tablet identification imprints. The defect affects 1,380 bottles distributed nationwide.

    Product
    VENLAFAXINE — VENLAFAXINE (VENLAFAXINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0830-2025·2025-01-22

    Impella RP Flex Devices Recalled Due to Optical Sensor Damage Risk

    Abiomed is recalling 2,364 units of the Impella RP Flex with SmartAssist due to risk of optical sensor damage from device interaction. Damage may cause temporary or permanent pump stop and loss of vital monitoring signals.

    Product
    Impella RP Flex with SmartAssist; Product Number: 1000323;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0884-2025·2025-01-22

    Welch Allyn Life 2000 Ventilator Battery Charger Defect Causes Inoperability

    The Welch Allyn Life 2000 Ventilator has a battery charger defect that could cause an alarm, rendering it inoperable. 187 units nationwide are affected in this FDA Class I recall.

    Product
    Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0425-2025·2025-01-22

    Wicklow Gold Cheddar Nettle & Chive Cheese recalled for possible Listeria contamination

    Abbey Specialty Foods is recalling Wicklow Gold Cheddar Nettle & Chive Cheese due to possible Listeria monocytogenes contamination. The product was distributed to Massachusetts, Colorado, and Ohio.

    Product
    Wicklow Gold Cheddar Nettle & Chive Cheese, 5.2 oz., plastic cryo-vac , 8 packages per case
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-0395-2025·2025-01-22

    Cucumber Spears Recalled Due to Potential Salmonella Contamination

    First Quality Produce is recalling Cucumber Spears in 5-lb trays due to potential Salmonella contamination. The recall affects distribution to 13 consignees in California.

    Product
    Cucumber Spear; 5-lb plastic trays Brand: First Quality Produce
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0825-2025·2025-01-22

    ALTRUA 2 DR Pacemaker Models S702 and S722 Safety Mode Risk

    Boston Scientific ALTRUA 2 DR Pacemakers may unexpectedly enter Safety Mode during normal operation due to high battery impedance, potentially affecting device functionality.

    Product
    ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0887-2025·2025-01-22

    Life2000 Ventilation System battery charger defect causes device inoperability

    Baxter Healthcare is recalling the Life2000 Ventilation System due to a battery charger defect that can trigger an alarm, rendering the ventilator inoperable and unable to support patients' breathing.

    Product
    Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0389-2025·2025-01-22

    Boar's Head hummus vegetable platter recalled for Salmonella contamination

    Boar's Head hummus platters are recalled because they may contain cucumbers previously recalled for potential Salmonella contamination. Products were distributed across multiple states.

    Product
    BOAR'S HEAD HUMMUS VEG PLATTER SM, 2.5 lb., packaged in a plastic container with a plastic lid, UPC 42421-61545
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0886-2025·2025-01-22

    Welch Allyn Life2000 Ventilator Battery Charger Malfunction Recall

    Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Ventilation Systems due to a battery charger malfunction that triggers an alarm and renders the ventilator inoperable.

    Product
    Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0388-2025·2025-01-22

    Small Veggie Platter Recalled for Potential Salmonella Contamination

    The Kroger Co is recalling Small Veggie Platters (32 oz) because they may contain cut cucumbers previously recalled due to potential Salmonella contamination.

    Product
    SMALL VEGGIE PLATTER, 32 oz., packaged in a plastic container with a plastic lid, UPC 41573-26809
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0824-2025·2025-01-22

    ESSENTIO DR Pacemakers May Malfunction Due to Battery Impedance Issue

    Boston Scientific is recalling certain ESSENTIO DR Pacemakers manufactured before September 2018 due to latent battery impedance that may cause Safety Mode malfunction during normal operations.

    Product
    ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0426-2025·2025-01-22

    Wicklow Gold Cheddar Cheese Recalled for Potential Listeria Contamination

    Abbey Specialty Foods is recalling Wicklow Gold Cheddar Tomato & Herb cheese distributed in Massachusetts, Colorado, and Ohio due to potential Listeria monocytogenes contamination.

    Product
    Wicklow Gold Cheddar Tomato & Herb, 5.2 oz., plastic cryo-vac , 8 packages per case
    Category
    Food
    Distribution
    3 states