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.

8501–8525 of 26961

  • HighFDA (Devices)·Z-0339-2025·2024-11-20

    IV Fluid Container Bags Recalled for Potential Leaks During Filling

    The Metrix Company is recalling SECURE 250 mL IV fluid containers due to leaks found during filling. Affected units were distributed nationwide and to Canada.

    Product
    SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2025·2024-11-20

    Stryker Neptune SafeAir Electrosurgical Pencil Recalled for Unintended Activation Risk

    Stryker has recalled over 1.1 million Neptune SafeAir Smoke Evacuation Pencils due to potential unintended activation that may cause electrical burns to patients and surgical staff. The device may activate without user input or remain active after buttons are released.

    Product
    Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0351-2025·2024-11-20

    Cystoscope Outer Sheath Recalled for Potential Laser Probe Damage

    Olympus is recalling 738 units of the WA22810A Cystoscope Outer Sheath distributed nationwide due to potential damage to the laser probe tip during use with GreenLight Laser for BPH therapy. The manufacturer removed this compatibility claim from product instructions.

    Product
    Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2025·2024-11-20

    Halyard Angiography Drape Pack Recalled for Potential Metal Flakes in Surgical Site

    AVID Medical recalls Halyard angiography drape packs due to potential metal flakes that could detach from sponge forceps and towel clamps. These flakes could enter a surgical site undetected and cause local or foreign body reactions.

    Product
    Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0330-2025·2024-11-20

    VYGON 100 mL IV Container Pouch Recalled for Potential Leakage

    The Metrix Company is recalling a limited number of VYGON 100 mL empty IV containers (Lot Numbers 62040-A8375 and 62040-A8432) due to leakage found during the filling process. The affected containers are distributed in multiple U.S. states and Canada.

    Product
    VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2025·2024-11-20

    Surgical instrument kits recalled for loose metal flakes

    AVID Medical is recalling Halyard CPT EP PACK surgical convenience kits due to loose metal flakes on forceps and towel clamps. Detached metal flakes could enter surgical sites and potentially cause local tissue reactions or foreign body complications.

    Product
    Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0358-2025·2024-11-20

    Medline Urine Collection Kits Recalled Due to Non-Sterile Specimen Containers

    Medline Industries recalls 626,305 urine collection kits with non-sterile specimen containers labeled as sterile. The kits may cause unnecessary treatment or prolonged hospitalization.

    Product
    URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0336-2025·2024-11-20

    IV Fluid Bags Found to Leak During Filling; Manufacturer Recalls Affected Units

    The Metrix Company is recalling 2549 cases of SECURE 100 mL empty IV fluid bags because a limited number were found to leak during filling, which could result in contamination during fluid administration.

    Product
    SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2025·2024-11-20

    Baxter Spectrum IQ Infusion Pump Door May Not Close Fully

    Baxter is recalling 8 units of its Spectrum IQ Infusion System with Dose IQ Safety Software because the pump door may not fully close. The recall affects units distributed in Georgia and Idaho.

    Product
    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0334-2025·2024-11-20

    IV Bag Containers Recalled for Leaking During Filling Process

    The Metrix Company is recalling CORMIX 500 mL IV bag containers that may leak during the filling process. These plastic pouches are intended for intravenous fluid administration.

    Product
    CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0368-2025·2024-11-20

    Stryker Neptune SafeAir Smoke Evacuation Pencil May Activate Unintentionally

    Stryker recalls Neptune SafeAir Smoke Evacuation Pencils that may activate without user input, risking electrical burns to patients or healthcare workers. Approximately 1,996,010 units were distributed worldwide.

    Product
    Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2025·2024-11-20

    MEERA CL operating table may stop unexpectedly during surgical procedures

    The MEERA CL operating table may experience error code 50037 on its IR-Hand Control, causing the table to stop mid-procedure. No injuries have been reported.

    Product
    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0399-2025·2024-11-20

    Surgical instrument kits recalled for potential loose metal flake hazard

    Halyard abdominal procedure surgical kits may contain loose metal flakes in forceps and clamps that could enter the surgical site. Affected kits have lot number 1590888.

    Product
    Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0446-2025·2024-11-20

    Halyard EP TRAY Surgical Kits Recalled for Loose Metal Flakes

    AVID Medical is recalling Halyard EP TRAY surgical convenience kits due to sponge forceps and towel clamps that may shed small metal flakes. These flakes could enter surgical sites, potentially causing local or foreign body reactions.

    Product
    Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2025·2024-11-20

    Imed EVA IV Fluid Bags Recalled Due to Leakage During Filling

    The Metrix Company is recalling Imed EVA IV fluid bags that may leak during filling. A limited number of units have been found defective across multiple U.S. states and Canada.

    Product
    Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2025·2024-11-20

    Urine Collection Kit Specimen Containers Recalled Due to Sterility Defect

    Medline Industries is recalling over 626,000 urine collection kits due to specimen containers labeled as sterile but identified as non-sterile. The defect may result in unnecessary treatment or prolonged hospitalization.

    Product
    URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0431-2025·2024-11-20

    Halyard CPT Cardiac Cath Pack Recalled Due to Loose Metal Flakes in Forceps and Clamps

    AVID Medical is recalling Halyard CPT Cardiac Cath Pack convenience kits due to small metal flakes that may detach from sponge forceps and towel clamps. Metal flakes could enter a surgical site undetected and cause local or foreign body reactions.

    Product
    Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0448-2025·2024-11-20

    Medical Convenience Kits Recalled for Potential Loose Metal Flakes in Surgical Instruments

    AVID Medical is recalling Halyard MANIFOLD CATH PACK medical convenience kits because sponge forceps and towel clamps may shed metal flakes that could contaminate surgical sites.

    Product
    Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0433-2025·2024-11-20

    Surgical forceps and clamps recalled due to detachable metal flakes

    AVID Medical is recalling Halyard CPT surgical convenience kits because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites. No illnesses have been reported.

    Product
    Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0131-2025·2024-11-20

    Home Chef Asian Style Chicken Stir Fry Recalled for Listeria Contamination

    The Kroger Co is recalling Home Chef Asian Style Chicken Stir Fry due to potential contamination with Listeria monocytogenes. The recall affects 31,424 consumer units distributed across the United States.

    Product
    Home Chef Asian Style Chicken Stir Fry, Net Wt. 13 oz, packaged in a plastic tray with clear plastic lid, perishable item kept under refrigeration, UPC 84013430852, all lot codes
    Category
    Food
    Distribution
    31 states
  • HighFDA (Devices)·Z-0435-2025·2024-11-20

    Halyard C Section Pack surgical kits recalled for loose metal flakes

    AVID Medical is recalling Halyard C Section Pack surgical kits due to loose metal flakes on sponge forceps and towel clamps. These flakes may enter a surgical site and cause local reactions or foreign body complications.

    Product
    Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0405-2025·2024-11-20

    Halyard GYN TRAY surgical kits recalled for loose metal flakes

    AVID Medical is recalling 136 units of Halyard GYN TRAY surgical kits due to small loose metal flakes that could detach from sponge forceps and towel clamps. These metal fragments could enter a patient's surgical site undetected, causing local or foreign body reactions.

    Product
    Halyard GYN TRAY - Medical convenience kits Model Number: LANC014-19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0337-2025·2024-11-20

    IV Fluid Pouches Found to Leak During Filling

    The Metrix Company is recalling SECURE 50 mL EVA containers used for intravenous fluid administration because a limited number of pouches have been found to leak during filling. Affected products were distributed nationwide and to Canada.

    Product
    SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2025·2024-11-20

    Halyard ANGIO PACK surgical kits recalled for loose metal fragments

    AVID Medical recalls Halyard ANGIO PACK surgical kits due to loose metal flakes that could detach and enter a patient's surgical site. The recall affects 284 units distributed nationwide.

    Product
    Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2025·2024-11-20

    Medline urine collection kits recalled for non-sterile specimen containers

    Medline has recalled 626,305 urine collection kits because specimen containers are labeled as sterile but are actually non-sterile, potentially leading to unnecessary treatment or prolonged hospitalization.

    Product
    URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide