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

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Minimum severity

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

Clear filters

21426–21450 of 27682

  • HighFDA (Devices)·Z-2074-2016·2016-07-06

    Pentax Naso-Pharyngo-Laryngoscope Recall Due to Lodged Accessories

    Pentax Medical Company is recalling 215 Naso-Pharyngo-Laryngoscopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2075-2016·2016-07-06

    Pentax Sigmoidoscopes Recalled Due to Risk of Lodged Accessories

    Pentax Medical Company is recalling 1,596 sigmoidoscopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2055-2016·2016-07-06

    Hospira Symbiq Infusion Pumps Recalled for Frequent False Occlusion Alarms

    Hospira is recalling Symbiq One Channel Infusers due to frequent false proximal occlusion alarms that may delay or interrupt patient therapy.

    Product
    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2016·2016-07-06

    Medtest Homocysteine Reagent Recalled for Performance Deterioration

    Medtest Holdings is recalling 13 kits of Liquid Stable 2-Part Homocysteine Reagent due to under-recovery of homocysteine in patient samples.

    Product
    Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2078-2016·2016-07-06

    Pentax Medical Recalls Ureteroscopes Due to Lodged Accessories Risk

    Pentax Medical is recalling 32 ureteroscopes because operational accessories may become lodged in the instrument channel.

    Product
    Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2090-2016·2016-07-06

    Smith & Nephew Recalls Legion HK Femoral Assemblies for Surface Defect

    Smith & Nephew is recalling 12 units of Legion HK Femoral Assemblies because the internal surface is below specification, potentially affecting cement adhesion.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2040-2016·2016-06-29

    Immuno-Mycologics Recalls Histoplasma Yeast Complement Fixation Antigen Due to Bacterial Contamination

    Immuno-Mycologics, Inc. is recalling 467 units of Histoplasma Yeast Complement Fixation Antigen Dilute (Lot 111WH3) due to bacterial contamination. The product was distributed nationwide to specific states.

    Product
    Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2017-2016·2016-06-29

    Siemens Biograph PET/CT Scanner Upgrade Recalled for Calibration Error

    Siemens Medical Solutions is recalling 2 Biograph TruePoint scanner upgrades because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2016·2016-06-29

    Fresenius CLiC Monitor Recall for Potential Hemodialysis Pump Stoppage

    Fresenius Medical Care is recalling 875 CLiC monitors used with 2008T hemodialysis machines because a frozen screen may cause the blood pump to stop.

    Product
    Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2005-2016·2016-06-29

    Siemens Biograph mCT-X 4R PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling 83 Biograph mCT-X 4R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2016·2016-06-29

    Fujifilm Synapse PACS Software Recall for Image Display Failure

    Fujifilm Medical Systems is recalling 27 units of Synapse PACS software versions 4.4.000 through 4.4.020 because the software fails to display medical images, showing an error message instead.

    Product
    Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation…
    Category
    Medical Device
    Distribution
    6 states
  • CriticalFDA (Devices)·Z-1891-2016·2016-06-22

    CareFusion Recalls AVEA Comprehensive Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Comprehensive ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1888-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Comprehensive ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1894-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Ventilators because a defective fuse on the TCA Board may fail, causing loss of power to the User Interface Module.

    Product
    TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1899-2016·2016-06-22

    CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect

    CareFusion is recalling AVEA GDE upgrade kits because an incorrect fuse may fail, causing loss of power to the ventilator's user interface.

    Product
    AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1889-2016·2016-06-22

    CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing a loss of power to the user interface module.

    Product
    AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1898-2016·2016-06-22

    CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect

    CareFusion is recalling AVEA Ventilator upgrade kits because an incorrect fuse may fail, causing loss of power to the User Interface Module.

    Product
    AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1897-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

    CareFusion is recalling 922 AVEA Ventilators worldwide because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1978-2016·2016-06-22

    Navilyst Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling specific Xcela Hybrid PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1890-2016·2016-06-22

    CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1896-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

    CareFusion is recalling AVEA Ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1893-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1895-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

    CareFusion is recalling AVEA Ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1892-2016·2016-06-22

    CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2016·2016-06-22

    Zimmer Dome Centric Shoulder Implant Component Recalled for Assembly Issues

    Zimmer GmbH is recalling 177 Dome Centric components from the Anatomical Shoulder System 2.0 because they may be difficult to disassemble during surgery, potentially causing delays or incomplete procedures.

    Product
    Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term…
    Category
    Medical Device
    Distribution
    Distributed nationwide