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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37401–37425 of 40449

  • ModerateFDA (Devices)·Z-0035-2014·2013-10-30

    Agfa IMPAX 5.2 DB Server Software Recall for Performance Issues

    Agfa Corp. is recalling IMPAX 5.2 DB Server software because older versions may cause system downtime or slow performance in medical imaging systems.

    Product
    IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0063-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because a hex wrench may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.ST_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0062-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kit Recall for Defective Hex Wrench

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some contain a hex wrench that may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0056-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Hex Wrench Defect

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some hex wrenches may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0065-2014·2013-10-30

    Varian Medical Recalls Breast Template System Due to Sterilization Defect

    Varian Medical Systems is recalling 3 sets of the VARISOURCE Breast Template System because the templates may bend and turn opaque after steam sterilization.

    Product
    VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0032-2014·2013-10-30

    Bio-Rad Recalls FSE Image Upgrade Kits Due to Data Export Issues

    Bio-Rad Laboratories is recalling 23 FSE Image Upgrade Kits because of a software issue that affects data export from the EVOLIS analyzer to Laboratory Information Systems.

    Product
    FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Devices)·Z-0053-2014·2013-10-30

    Alere Triage TOX Drug Screen Control 1 Recalled Due to Code Chip Failure

    Alere San Diego, Inc. is voluntarily recalling Alere Triage TOX Drug Screen Control 1 because a provided code chip causes the control to fail in QC Sample Mode.

    Product
    Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0043-2014·2013-10-30

    Advanced Sterilization Products Recalls STERRAD 200 Sterilizers for Odor Emission

    Advanced Sterilization Products is recalling STERRAD 200 Sterilizers because they may emit unusual odors into the surrounding environment.

    Product
    STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0010-2014·2013-10-23

    GE Healthcare Recalls Ventilators and Anesthesia Machines with Unresponsive Buttons

    GE Healthcare is recalling 911 ventilators and anesthesia machines because manufacturing defects may cause display buttons to fail, preventing access to menu functions.

    Product
    GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0009-2014·2013-10-23

    GE Healthcare Recalls Anesthesia Devices Due to Tidal Volume Overdelivery Risk

    GE Healthcare is recalling specific anesthesia devices because they may deliver excessive tidal volume in a specific ventilation mode, posing a risk of harm to patients.

    Product
    GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2014·2013-10-23

    GE PET Discovery 610 and 710 Recalled for Image Series UID Conflict

    GE Healthcare is recalling PET scanners because a software issue may cause different image series to share the same ID, potentially leading to incorrect image display.

    Product
    GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2014·2013-10-23

    Boston Scientific COGNIS CRT-D Recall for Premature Battery Depletion

    Boston Scientific is recalling COGNIS CRT-D devices because a capacitor defect may cause premature battery depletion.

    Product
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0026-2014·2013-10-23

    Boston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion Risk

    Boston Scientific is recalling TELIGEN implantable cardiac defibrillators because a capacitor defect may cause premature battery depletion.

    Product
    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0011-2014·2013-10-23

    Siemens Recalls ADVIA Hematology Systems Due to Sample Labeling Error Risk

    Siemens is recalling ADVIA 2120/2120i hematology systems connected to an ADVIA Autoslide because a rack jam error could cause the next slide to be labeled with the wrong sample identification information.

    Product
    ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0014-2014·2013-10-23

    Synthes Midfoot Fusion Bolt Recall for Technique Guide Clarification

    Synthes USA is recalling 62 Midfoot Fusion Bolts to update the technique guide, emphasizing supplemental fixation to reduce the risk of bolt back-out or migration.

    Product
    Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2014·2013-10-23

    Getinge 46-Series Washer-Disinfectors Recalled for Overheating Risk

    Getinge Disinfection is recalling 46-Series medical washer-disinfectors due to a possible overheating hazard. The voluntary field safety correction affects 143 units distributed in the US and Canada.

    Product
    Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0012-2014·2013-10-23

    GE Healthcare X-ray Systems Recalled for Loose Power Assist Handle Bolts

    GE Healthcare is recalling 810 X-ray systems because internal bolts on the power assist handle may loosen or fall out, potentially causing the handle to stick in the ON position.

    Product
    GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0022-2014·2013-10-23

    Harvest Graft Delivery System Recalled for Potential Luer Connector Leaks

    Harvest Technologies is recalling 730 cases of the Harvest Graft Delivery System because the Luer connector may leak or crack.

    Product
    Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2014·2013-10-23

    Philips MX 16-Slice CT Scanner Recalled for Pinch Point Injury Risk

    Philips Medical Systems is recalling 326 MX 16-Slice CT Scanner Systems because a pinch point at the end of the table top can cause injury.

    Product
    MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0015-2014·2013-10-23

    OSOM C. Difficile Toxin A/B Test Kit Recalled for False Negative Risk

    Sekisui Diagnostics is recalling specific lots of the OSOM C. Difficile Toxin A/B Test Kit due to the potential for false negative results.

    Product
    Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0021-2014·2013-10-23

    GE Healthcare Recalls X-ray Systems Due to Missing Monitor Screws

    GE Healthcare is recalling specific X-ray imaging systems because missing screws in the overhead video monitor suspension could create a safety hazard.

    Product
    GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0020-2014·2013-10-23

    Abbott Clinical Chemistry Phosphorus Reagent Recalled for Incorrect Expiration Dates

    Abbott Laboratories is recalling specific lots of Clinical Chemistry Phosphorus Reagent because the supplier assigned incorrect expiration dates to the product.

    Product
    Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0017-2014·2013-10-23

    Siemens Recalls Dimension Vista Urinary Protein Reagent Cartridges

    Siemens is recalling Dimension Vista Urinary/Cerebrospinal Fluid Protein reagent cartridges due to confirmed absorbance errors during calibration.

    Product
    Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0027-2014·2013-10-23

    SonoSite P21x/5-1 Transducer Recalled for Biopsy Bracket Sensor Defect

    SonoSite, Inc. is recalling 10 P21x/5-1 MHz transducers because the Biopsy Bracket Sensor is not working as intended.

    Product
    P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0023-2014·2013-10-23

    GE Optima CT660 Recalled for Potential Series UID Generation Error

    GE Healthcare is recalling Optima CT660 scanners because the DMPR and Screen Save functions may generate duplicate Series UIDs, potentially causing PACS systems to combine patient series incorrectly.

    Product
    GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    Distributed nationwide