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.

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Minimum severity

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

Clear filters

22076–22100 of 27699

  • CriticalFDA (Devices)·Z-1058-2016·2016-03-16

    Arrow Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding Risk

    Arrow International is recalling Ultra 8 IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1059-2016·2016-03-16

    Arrow UltraFlex IAB Recall: Sheath Separation Risk

    Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1061-2016·2016-03-16

    Arrow RediGuard IAB Recall Due to Sheath Separation Risk

    Arrow International is recalling RediGuard IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1057-2016·2016-03-16

    Arrow FiberOptix Ultra 8 IAB recalled for potential sheath separation

    Arrow International is recalling FiberOptix Ultra 8 IAB devices because the sheath body may separate from the hub, posing a risk of bleeding.

    Product
    FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1081-2016·2016-03-16

    Stryker Position Pro Mattress Recalled for Power Cord Fire Risk

    Stryker is recalling Position Pro Mattresses because the power cord may melt, posing risks of electric shock and fire.

    Product
    Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1056-2016·2016-03-16

    Arrow Ultra 8 IAB Recalled for Potential Sheath Separation and Bleeding

    Arrow International is recalling Ultra 8 IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1055-2016·2016-03-16

    Arrow FiberOptix Ultra 8 IAB Recalled for Potential Sheath Separation

    Arrow International is recalling FiberOptix Ultra 8 IAB devices because the sheath body may separate from the hub, creating a risk of bleeding.

    Product
    FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1035-2016·2016-03-16

    Verathon Recalls GlideScope Titanium Video Laryngoscope Blades Due to Image Flickering

    Verathon is recalling GlideScope Titanium single-use video laryngoscope blades because the video image may flicker or distort during use.

    Product
    GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1060-2016·2016-03-16

    Arrow UltraFlex IAB Recall for Potential Sheath Separation and Bleeding Risk

    Arrow International is recalling UltraFlex IAB devices because the sheath body may separate from the hub, creating a potential for bleeding.

    Product
    UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0911-2016·2016-03-16

    Abbott Vascular Recalls MitraClip Clip Delivery System Due to Mandrel Fracture

    Abbott Vascular is recalling the MitraClip Clip Delivery System because a mandrel fracture may prevent the clip from detaching during implantation.

    Product
    MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. The MitraClip Clip Delivery System (CDS)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1062-2016·2016-03-16

    Arrow Percutaneous Insertion Tray Recalled for Potential Sheath Separation

    Arrow International is recalling specific Percutaneous Insertion Trays because the sheath body may separate from the hub, posing a risk of bleeding.

    Product
    Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2016·2016-03-16

    Gi Supply Recalls Large Volume Paracentesis Kits Due to Missing Clamp

    Gi Supply is recalling Large Volume Paracentesis Kits because the pinch clamp on the RP Bag may be missing, posing a splash hazard to users.

    Product
    Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag. Catalog #: GIS-28 Lot #: 61442434 Expiration Date: 2018/04
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1076-2016·2016-03-16

    BD Intelliport Medication Management System Sensor Recalled for Sterility Concerns

    Becton Dickinson is recalling 250 units of the BD Intelliport Medication Management System Sensor because the sterility of the product cannot be assured, posing an increased risk of infection.

    Product
    BD Intelliport Medication Management System Sensor The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1068-2016·2016-03-16

    Bard Denali Filter Delivery System Recalled for Cracking Stop Cocks

    Bard Peripheral Vascular is recalling Denali Filter Delivery Systems because stop cocks may crack.

    Product
    Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1065-2016·2016-03-16

    Philips Respironics Recalls Trilogy and Garbin Ventilators Due to Software Issue

    Philips Respironics is recalling approximately 104,508 Trilogy and Garbin ventilators due to a software issue. The recall covers units distributed nationwide and internationally.

    Product
    Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2016·2016-03-16

    Sedecal Mobile X-ray Systems Recalled for Uncommanded Movements

    Sedecal S.A. is recalling 349 mobile X-ray systems because static electricity and other issues can cause uncommanded movements.

    Product
    Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1064-2016·2016-03-16

    Arrow Recalls Percutaneous Sheath Introducer Sets Due to Packaging Damage

    Arrow International Inc. is recalling Super Arrow-Flex Percutaneous Sheath Introducer Sets because packaging damage may compromise sterility, posing a potential infection risk.

    Product
    Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band Contents: 1: . . . . . . . . . Sheath*: ***…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2016·2016-03-16

    Bard Denali Filter Delivery Systems Recalled for Cracking Stop Cocks

    Bard Peripheral Vascular is recalling Denali Filter Delivery Systems because stop cocks may crack.

    Product
    Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2016·2016-03-16

    Biomet Recalls Crosslock DVR ePAK Surgical Sets Due to Oxidation Risk

    Biomet is recalling 21,268 Crosslock DVR ePAK surgical sets because components may oxidize during storage. This could cause an inflammatory reaction if material enters the surgical wound.

    Product
    Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2016·2016-03-16

    Spacelabs Xhibit Central Station Recalled for Height and Weight Input Error

    Spacelabs Healthcare is recalling Xhibit Central Station units because patient height and weight values may be switched, causing incorrect Body Surface Area calculations.

    Product
    Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-1080-2016·2016-03-16

    FDA Recalls Custom Tubing Extensions Due to Potential Cracking

    Value Plastics is recalling 33,000 custom tubing extensions because the parts may crack. The devices were distributed to three consignees in New York, Pennsylvania, and Minnesota.

    Product
    Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1024-2016·2016-03-09

    Philips SENSE Body Coil 1.5T Recalled for Potential Patient Burns

    Philips is recalling 5,672 SENSE Body Coil 1.5T units because improper cable placement can cause patient burns during MRI scans.

    Product
    SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1027-2016·2016-03-09

    NeoCoil 3.0T GEM Flex Coil Recalled for Potential Burn Risk

    NeoCoil, LLC is recalling 2,121 units of the 3.0T GEM Flex Coil system due to a potential for higher than specified surface temperatures that may result in patient warming or burns.

    Product
    NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2016·2016-03-09

    Mako Surgical Recalls Restoris Knee Implants Due to Packaging Damage

    Mako Surgical Corporation is recalling 146 units of the Restoris Multicompartmental Knee System because damaged packaging may have compromised the sterile barrier.

    Product
    Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2016·2016-03-09

    Cook Inc. Recalls Kopans Breast Lesion Localization Needles

    Cook Inc. is recalling 134 Kopans Breast Lesion Localization Needles because they may have been exposed to body fluids during processing, posing a potential risk of blood-borne pathogen transmission.

    Product
    Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip…
    Category
    Medical Device
    Distribution
    Distributed nationwide