The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

19376–19400 of 27682

  • HighFDA (Devices)·Z-2694-2017·2017-07-19

    St. Jude Medical Recalls Infinity 5 Implantable Pulse Generators

    St. Jude Medical is recalling 54 Infinity 5 Implantable Pulse Generators due to a risk of therapy loss if exposed to monopolar electrosurgical devices.

    Product
    Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2700-2017·2017-07-19

    CareFusion Recalls Alaris Pump Module 8100 Due to Latch Design Risk

    CareFusion 303, Inc. is recalling 35,940 Alaris Pump Module model 8100 units in the US and Canada due to a potential risk of unintended flow caused by the sear door latch design.

    Product
    Alaris Pump Module model 8100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2731-2017·2017-07-19

    O-Two Medical Recalls Burn Relief Dressings Due to Sterilization Concerns

    O-Two Medical Technologies is voluntarily recalling specific lots of Burn Relief hydrogel dressings because there is a lack of evidence validating the sterilization dose, posing a potential contamination risk.

    Product
    Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2696-2017·2017-07-19

    St. Jude Medical Recalls Infinity 7 Implantable Pulse Generators

    St. Jude Medical is recalling 40 Infinity 7 Implantable Pulse Generators because exposure to monopolar electrosurgical devices during medical procedures may cause a loss of neuromodulation therapy.

    Product
    Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2717-2017·2017-07-19

    ICU Medical Recalls Smallbore Extension Sets Due to Potential Leak

    ICU Medical is recalling 120 units of smallbore extension sets because the connection between the Female Luer and NanoClave manifold may develop a leak.

    Product
    168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, MicroClave¿ Clear, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2677-2017·2017-07-19

    ICU Recalls 71 Plum A+ Infusion Systems Due to Battery Error

    ICU is recalling 71 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2681-2017·2017-07-19

    ICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption

    ICU is recalling 21,703 Plum A+ Infusion Systems because battery issues can cause an E321 error code, potentially interrupting therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2676-2017·2017-07-19

    ICU Recalls Plum A+ Infusion Systems Due to Battery-Related Therapy Interruption

    ICU is recalling 10,609 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting patient therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2723-2017·2017-07-19

    ICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 1,100 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2718-2017·2017-07-19

    ICU Medical Recalls 28 cm Bifuse Extension Sets Due to Leak Risk

    ICU Medical is recalling 50 units of 28 cm Bifuse Extension Sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2703-2017·2017-07-19

    GE Healthcare Recalls Carestation Monitors for Potential Malfunction

    GE Healthcare is recalling Carestation 620, 650, and 650c monitors due to potential for elevated FiCO2 readings and unexpected system malfunctions.

    Product
    Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-2675-2017·2017-07-19

    ICU Recalls 180 Plum A+ Infusion Systems Due to Battery Issues

    ICU is recalling 180 Plum A+ Infusion Systems because battery issues may cause an E321 error code and interrupt therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2709-2017·2017-07-19

    Toshiba XARIO 200 Ultrasound System Recalled for Incorrect Velocity Trace Values

    Toshiba American Medical Systems is recalling XARIO 200 diagnostic ultrasound systems because the Continuous Trace method may display incorrect velocity trace values.

    Product
    XARIO 200 TUS-X200 diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2697-2017·2017-07-19

    Elekta Leksell Gamma Knife Icon Recall for Electrical Safety Risk

    Elekta is recalling two Leksell Gamma Knife Icon units due to a potential electrical safety risk for technicians performing maintenance.

    Product
    Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g., metastatic tumors, recurrent glioblastomas, trigeminal neuralgia, medically refractory…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2713-2017·2017-07-19

    Pentax Video Duodenoscope Recall for Surface Soiling Investigation

    Pentax of America Inc. issued a field correction for two Video Duodenoscope models to investigate surface soiling on the suction cylinder and distal cap.

    Product
    Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2682-2017·2017-07-19

    ICU Recalls Plum A+ Infusion Systems Due to Battery Error

    ICU is recalling 7,351 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2719-2017·2017-07-19

    ICU Medical Recalls 28 cm Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 6 units of 28 cm Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may develop a leak.

    Product
    28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2728-2017·2017-07-19

    Natus Neurology Recalls Elite Obstetric Probes Due to Excessive Background Noise

    Natus Neurology is recalling 2,335 Elite Obstetric probes because excessive background noise may mask heart rate and blood flow sounds.

    Product
    Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2720-2017·2017-07-19

    ICU Medical Recalls Proximale Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 70 units of Proximale Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may develop a leak.

    Product
    PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2680-2017·2017-07-19

    ICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption

    ICU is recalling 7,848 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting patient therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2678-2017·2017-07-19

    ICU Recalls 214 Plum A+ Infusion Systems Due to Battery Error

    ICU is recalling 214 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2691-2017·2017-07-19

    St. Jude Medical Recalls Proclaim 5 Elite Implantable Pulse Generators

    St. Jude Medical is recalling 8,780 Proclaim 5 Elite implantable pulse generators due to a risk of losing neuromodulation therapy when exposed to monopolar electrosurgical devices.

    Product
    Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2707-2017·2017-07-19

    Merge Healthcare Recalls Schiller PB 1000 Patient Data Module

    Merge Healthcare is recalling 555 Schiller PB 1000 Patient Data Modules because the analog output may not accurately reflect the pressure waveform used for fractional flow reserve calculations.

    Product
    The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2726-2017·2017-07-19

    Natus Neurology Recalls Elite 2 MHz OB Probes Due to Excessive Noise

    Natus Neurology is recalling 2,335 Elite 2 MHz OB probes because excessive background noise may mask the user's ability to hear heart rate or blood flow.

    Product
    Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
    Category
    Medical Device
    Distribution
    44 states