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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25226–25250 of 27722

  • SevereFDA (Devices)·Z-1298-2014·2014-04-09

    Draeger PS500 Power Supply Unit Recalled Due to Reduced Battery Capacity

    Draeger Medical Systems is recalling 1,544 PS500 Power Supply Units because the battery capacity did not last as long as expected.

    Product
    Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1308-2014·2014-04-09

    RaySearch Ray Station 4.0 software recalled for dose calculation errors

    RaySearch Laboratories is recalling Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.

    Product
    RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1311-2014·2014-04-09

    Zoll Medical Defibrillators Recalled for Continuous Device Reset Loop

    Zoll Medical is recalling 3,169 defibrillator/pacemaker/monitor units because they may latch in a continuous reset loop, rendering them unusable.

    Product
    Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1325-2014·2014-04-09

    Teleflex Recalls Weck Vista Optical Bladeless Laparoscopic Access Ports

    Teleflex Medical is recalling 55,521 Weck Vista Optical Bladeless Laparoscopic Access Ports due to complaints of insufflation gas leakage.

    Product
    5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405912R. An endoscope and accessories is a device used to provide access, illumination, and allow observation or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1324-2014·2014-04-09

    Teleflex Medical Recalls Weck Vista Cannulas Due to Gas Leakage

    Teleflex Medical is recalling 55,521 units of 10mm and 12mm Weck Vista Cannulas because they may leak insufflation gas.

    Product
    10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1309-2014·2014-04-09

    Siemens Artis Zee Angiographic Systems Recalled for Cable Connection Defect

    Siemens Medical Solutions is recalling nine Artis Zee Angiographic x-ray systems due to an inappropriate cable connection that may cause system failure and restricted gantry maneuverability.

    Product
    Artis Zee Angiographic x-ray systems.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1329-2014·2014-04-09

    Ethicon Proceed Surgical Mesh Recalled for Potential Sterility Compromise

    Ethicon is recalling 223 units of Proceed Surgical Mesh due to a possible incomplete packaging seal that may have compromised sterility and caused delamination.

    Product
    Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1326-2014·2014-04-09

    Teleflex Medical Recalls Weck Vista Universal Cannulas Due to Gas Leakage

    Teleflex Medical is recalling 55,521 Weck Vista Universal Cannulas because they may leak insufflation gas during use.

    Product
    5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista Universal Cannula, Catalog No. 405912RC. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1327-2014·2014-04-09

    Teleflex Medical Recalls Weck Vista Universal Cone Open Access Devices

    Teleflex Medical is recalling 55,521 Weck Vista Universal Cone Open Access devices due to complaints of insufflation gas leakage.

    Product
    5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2014·2014-04-09

    Elekta Integrity Software Recalled for Incorrect Radiation Beam Delivery Tolerances

    Elekta, Inc. is recalling Integrity 1.1 software because it uses static calibration tolerances instead of calculated values for radiation delivery.

    Product
    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1319-2014·2014-04-09

    Merit Medical Pressure Monitoring Tubing Recalled for Sterilization Failure

    Merit Medical Systems is recalling 80 units of Pressure Monitoring Tubing PM6006 because the products were labeled as sterile but were not sterilized.

    Product
    Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1315-2014·2014-04-09

    Roche Omni Micro-electrode Recalled for Potential Leakage and Erroneous Results

    Roche Diagnostics is recalling Omni Micro-electrodes for cobas b221 analyzers because they may leak if used beyond their 52-week lifetime, potentially causing erroneous pH and sodium results.

    Product
    Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1323-2014·2014-04-09

    Teleflex Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage

    Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports worldwide because they may leak insufflation gas during use.

    Product
    Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Catalog No. 405912; Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 125mm, Catalog No. 40591213. An endoscope and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2014·2014-04-09

    Allesee Orthodontic Jet Appliances Recalled Due to Missing Screw Collar

    Allesee Orthodontic Appliances is recalling 411 Jet appliances because a missing screw collar may prevent intended tooth movement.

    Product
    AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2014·2014-04-09

    Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports

    Teleflex Medical is recalling 55,521 units of Weck Vista Universal Balloon Open Access Ports due to complaints of leakage of insufflation gas through the device.

    Product
    5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port - Long Length (100mm), Catalog No. 410944L; 5/10 Weck Vista Universal Balloon Open Access Port - Short Length (53mm), Catalog No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2014·2014-04-09

    3M Steri-Vac Gas Sterilizers Recalled for Ethylene Oxide Exposure Risk

    3M is recalling Steri-Vac Gas Sterilizers due to a rare failure that could cause ethylene oxide exposure. The issue affects specific models manufactured in late 2006 and 2007.

    Product
    3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for INDOOR USE ONLY.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2014·2014-04-09

    Siemens ACUSON P300 Ultrasound Systems Recalled for Transducer Overheating

    Siemens is recalling ACUSON P300 ultrasound systems with PA230 transducers because they may exceed maximum allowable surface temperature limits.

    Product
    Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1330-2014·2014-04-09

    Ormco Recalls Spirit MB Orthodontic Brackets Due to Misplaced ID Dot

    Ormco/Sybronendo is recalling 150 Spirit MB Orthodontic Brackets because a misplaced ID dot may cause incorrect tooth placement.

    Product
    Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1316-2014·2014-04-09

    Siemens Medical Solutions Recalls IMMULITE 2000 and VersaCell Diagnostic Instruments

    Siemens Medical Solutions Diagnostics is recalling 1,006 IMMULITE 2000, IMMULITE 2000XPi, and VersaCell systems due to a potential for incorrect test results.

    Product
    IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2014·2014-04-09

    RayStation Radiation Therapy Software Recalled for Potential Dose Errors

    RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software due to potential dose errors caused by program errors.

    Product
    RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1312-2014·2014-04-09

    Philips Pinnacle3 Radiation Therapy Planning System Software Recall

    Philips is recalling Pinnacle3 Radiation Therapy Planning System software version 9.0 due to a defect that can cause incorrect beam geometry.

    Product
    Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
    Category
    Medical Device
    Distribution
    49 states
  • CriticalFDA (Devices)·Z-1227-2014·2014-04-02

    Thoratec HeartMate II Implant Kit Recalled Due to Controller Switching Injuries

    Thoratec is recalling HeartMate II Implant Kits because serious injuries and deaths occurred when patients switched from primary to backup System controllers.

    Product
    HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1230-2014·2014-04-02

    Thoratec HeartMate II Pocket Controllers Recalled Due to Reported Deaths

    Thoratec is recalling HeartMate II Pocket Controllers because serious injuries and deaths were reported when patients switched from primary to backup controllers.

    Product
    Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1228-2014·2014-04-02

    Thoratec HeartMate II System Controller Recalled Due to Injury and Death Reports

    Thoratec is recalling HeartMate II System Controllers because serious injuries and deaths occurred when patients switched from primary to backup controllers.

    Product
    HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-229-2014·2014-04-02

    Thoratec HeartMate II LVAD Pump Recall Due to Controller Switching Injuries

    Thoratec is recalling 36 HeartMate II LVAD Pump and Pocket Controller Kits because switching from the primary to the backup controller caused serious injuries and deaths.

    Product
    HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
    Category
    Medical Device
    Distribution
    Distributed nationwide