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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23701–23725 of 27699

  • SevereFDA (Devices)·Z-1240-2015·2015-03-11

    Richard Wolf I-Cart Medical Video Equipment Recall for Overheating Transformers

    Richard Wolf Medical Instruments Corp. is recalling 83 I-Cart units because transformers may overheat, causing smoke and black plastic material to leak from the chassis.

    Product
    The I-Cart is used to store, transport, and power video equipment used in medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1209-2015·2015-03-11

    Boston Scientific Recalls IntellaTip MiFi Radiofrequency Ablation Catheters

    Boston Scientific is recalling 14 IntellaTip MiFi radiofrequency ablation catheters due to reports of char formation on the distal tip electrodes.

    Product
    IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1242-2015·2015-03-11

    Biosense Webster Recalls LASSO NAV Duo Loop eco Catheters

    Biosense Webster is recalling LASSO NAV Duo Loop eco Catheters due to reports of difficulty retracting and damage to the spine cover.

    Product
    LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2015·2015-03-11

    Zipline Medical Recalls Zip 8i Surgical Skin Closure Devices

    Zipline Medical is recalling Zip 8i Surgical Skin Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.

    Product
    Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2015·2015-03-11

    Philips Allura Xper X-Ray Angiographic Software Recall

    Philips Medical Systems is recalling Allura Xper X-Ray Angiographic systems due to a software error that may prevent the five-minute fluoroscopy audible signal from sounding.

    Product
    Philips Medical System Allura Xper X-Ray Angiographic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2015·2015-03-11

    Zipline Medical Recalls Zip 16 Surgical Skin Closure Devices

    Zipline Medical is recalling Zip 16 Surgical Skin Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.

    Product
    Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2015·2015-03-11

    iCAD Recalls DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2

    iCAD, Inc. is recalling DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 because a device malfunction may cause biopsy needles to miss targets, potentially leading to incorrect diagnoses.

    Product
    DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2015·2015-03-11

    Maquet Servo-I Ventilator CO2 Analyzer Recalled for Calibration Defect

    Maquet is recalling 486 Servo-I ventilator CO2 analyzers worldwide due to a calibration problem caused by an internal circuit board defect.

    Product
    Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2015·2015-03-11

    Zipline Medical Recalls Zip 8M Wound Closure Devices Due to Sterility Concerns

    Zipline Medical is recalling Zip 8M Wound Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.

    Product
    Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1220-2015·2015-03-11

    Halyard Health Recalls KimVent Closed Suction Systems Due to Defects

    Halyard Health is recalling KimVent Closed Suction Systems for Adults because a hole or crack was found that may cause air to leak.

    Product
    KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1221-2015·2015-03-11

    Halyard Health Recalls KimVent Closed Suction Systems Due to Air Leak Defect

    Halyard Health is recalling KimVent Closed Suction Systems for Adults because a hole or crack may cause air to leak. The recall affects 5 cases distributed to specific US states and Japan.

    Product
    KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1237-2015·2015-03-11

    Elekta Monaco Radiation Therapy System Recalled for Incorrect CT to ED Conversion

    Elekta, Inc. is recalling Monaco radiation therapy treatment planning systems because the Image Statistics Tool may incorrectly convert CT to ED values.

    Product
    Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2015·2015-03-11

    Halyard Health Recalls KimVent Wet Pak Closed Suction Systems

    Halyard Health is recalling KimVent Wet Pak closed suction systems because a defect may cause air leaks.

    Product
    KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1244-2015·2015-03-11

    Elekta Focal Sim radiation therapy system recalled for image statistics error

    Elekta, Inc. is recalling 907 Focal Sim radiation therapy treatment planning systems because the Monaco Image Statistics Tool may produce incorrect CT to ED values.

    Product
    Focal Sim radiation therapy treatment planning system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2015·2015-03-11

    Siemens ADVIA Centaur Progesterone Kit Recalled for High Bias in Results

    Siemens is recalling ADVIA Centaur Systems Progesterone Kits because results above 30 ng/mL show high bias. The recall covers 11,980 kits distributed worldwide.

    Product
    ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2015·2015-03-11

    Xoran MiniCAT X-ray devices recalled for imaging and dose defects

    Xoran Technologies is recalling 432 MiniCAT X-ray imaging devices nationwide due to out-of-tolerance kVp, unexposed frames, and out-of-tolerance dose.

    Product
    Xoran MiniCAT X-ray imaging device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2015·2015-03-11

    Ikaria INOmax DSIR Nitric Oxide Delivery System Recalled for Alarm Defect

    INO Therapeutics is recalling 45 INOmax DSIR units because a specific software and display combination may trigger false alarms, interrupting nitric oxide therapy.

    Product
    Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1137-2015·2015-03-04

    Invacare TDX Electric Wheelchairs Recalled for Fire Hazard

    Invacare is recalling 1,942 TDX, FDX, and Storm Series power wheelchairs because wire pinching can cause smoking, sparking, or fire.

    Product
    TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1075-2015·2015-03-04

    Hospira Recalls Plum A+ Infusion Pumps Due to Alarm Failure

    Hospira is recalling 190 Plum A+ infusion pumps because their alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or…
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-1131-2015·2015-03-04

    HeartWare Controller Recall Due to Higher Susceptibility to Electrostatic Discharge

    HeartWare Inc is recalling 4,845 HeartWare Controllers used in ventricular assist systems because they are more susceptible to electrostatic discharge (ESD) than newer models.

    Product
    HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1138-2015·2015-03-04

    Invacare FDX Electric Wheelchairs Recalled for Fire Hazard

    Invacare is recalling 60 FDX, TDX, and Storm Series power wheelchairs because wire damage can cause smoking, sparking, or fire.

    Product
    FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1139-2015·2015-03-04

    Invacare Electric Wheelchair Recall for Fire Hazard

    Invacare is recalling 525 electric wheelchairs because a seating defect can pinch wires, potentially causing smoking, sparking, or fire.

    Product
    Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1073-2015·2015-03-04

    Hospira Recalls Plum A+ Infusion Pumps with Silent Alarm Defect

    Hospira is recalling 4,656 Plum A+ infusion pumps because one lot of alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or…
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-1072-2015·2015-03-04

    Hospira Plum A+ Infusion Pump Alarm Assembly Recall

    Hospira is recalling 3,939 Plum A+ infusion pumps because one lot of alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or…
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-1074-2015·2015-03-04

    Hospira Recalls Plum A+ Infusion Pumps With Silent Alarm Defect

    Hospira is recalling nine Plum A+ infusion pumps because their alarm assemblies may fail to sound at any volume level.

    Product
    The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or…
    Category
    Medical Device
    Distribution
    50 states