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.

7601–7625 of 27089

  • HighFDA (Devices)·Z-0994-2025·2025-01-29

    Olympus Thunderbeat Hand Instrument Probe Tips May Break or Detach

    Olympus is recalling the Thunderbeat surgical hand instrument because the probe tips are being damaged or breaking. The recall affects 34,325 units distributed in the US and internationally.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, sing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2025·2025-01-29

    Olympus Thunderbeat surgical instrument probe tips breaking and detaching

    Olympus is recalling Thunderbeat surgical instruments due to probe tip damage, breaking, and pad detachment.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5000687 Software Version: N/A Product Description: Thunderbeat instrument is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0419-2025·2025-01-29

    Butter Toffee Almonds recalled for undeclared milk allergen

    Cal Yee Farm LLC recalls Butter Toffee Almonds for undeclared milk. Products affected: Cal Yee's (8-oz, 1-lb bags) and Boa Vista (6-oz bag). Distribution: 2 California retail stores and online/phone orders to California and Pennsylvania.

    Product
    Cal Yee's Butter Toffee Almonds (8-oz, 1-lb plastic bags) Boa Vista Butter Toffee Almonds (6-oz plastic bag)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1009-2025·2025-01-29

    Baxter Solution Set with Duo-Vent Spike Recalled for Inverted Clamps

    Baxter Healthcare is recalling specific lots of its Solution Set with Duo-Vent Spike due to inverted side clamps that may render the tubing unusable. The affected product was distributed nationwide.

    Product
    Baxter Solution Set with Duo-Vent Spike, REF 2R8404
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0995-2025·2025-01-29

    Olympus Thunderbeat Surgical Hand Instruments Recalled for Damaged Probe Tips

    Olympus has recalled Thunderbeat surgical hand instruments because the probe tips can become damaged or broken, including pad damage and detachment. The recall affects 36,712 units distributed internationally outside the United States.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424030 Software Version: N/A Product Description: Thunderbeat instrument is a s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0974-2025·2025-01-29

    BD Pyxis MedStation 4000 Medication Cabinet Drawer and Door Failures

    CareFusion 303 is recalling 5,056 BD Pyxis MedStation 4000 AUX units worldwide due to drawer and door failures that may delay medication access. Failures include door latch failure, cable ribbon damage, and magnet falling out.

    Product
    BD Pyxis MedStation 4000 AUX, REF 306
    Category
    Medical Device
    Distribution
    0 states
  • 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 (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-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 (Devices)·Z-0986-2025·2025-01-29

    Medtronic Arterial Cannula Recall Due to Incorrect Labeling

    Medtronic Perfusion Systems is recalling Select Series Angled Tip Arterial Cannulas (Model 72422) due to incorrect labeling. The recall involves 440 units distributed nationwide.

    Product
    Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0977-2025·2025-01-29

    Programmable Valve Device Recalled Due to Incorrect Product Description Labels

    CODMAN CERTAS Plus Programmable Valve (Model 828810) units were distributed with incorrect product descriptions on labels. 132 units affected across multiple U.S. states and international locations.

    Product
    CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 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-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-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 surgic
    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 (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-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-0969-2025·2025-01-29

    Otological Ventilation Tubes Recalled for Lack of FDA 510(k) Clearance

    Adept Medical Ltd is recalling 2,440 otological ventilation tubes due to lack of FDA 510(k) regulatory clearance. The recall affects 1,940 units in the US and 500 units distributed internationally.

    Product
    Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
    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-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 (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-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