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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23926–23950 of 27663

  • SevereFDA (Devices)·Z-0824-2015·2014-12-24

    Zimmer Manufacturing Recalls Self-Tapping Bone Screws Due to Fracture Risk

    Zimmer Manufacturing B.V. is recalling 6,377 self-tapping bone screws used in hip surgery due to fractures caused by specific tool marks.

    Product
    Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0828-2015·2014-12-24

    Mako Surgical Recalls RESTORIS PST Straight Shell Impactors

    Mako Surgical Corporation is recalling 404 RESTORIS PST Straight Shell Impactors because they may be damaged during surgery.

    Product
    RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2015·2014-12-24

    Philips EPIQ 5 Ultrasound System Recalled for Incorrect Ejection Fraction Calculations

    Philips is recalling EPIQ 5 Ultrasound Systems because specific software plug-ins may calculate incorrect ejection fractions, potentially leading to misdiagnosis or delayed therapy.

    Product
    EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0818-2015·2014-12-24

    Philips Q-Station Software Recalled for Potential Incorrect Cardiac Measurements

    Philips is recalling Q-Station 3.0 software because automated cardiac measurements may be inaccurate, potentially leading to misdiagnosis or incorrect therapy.

    Product
    Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0817-2015·2014-12-24

    Philips EPIQ 7 Ultrasound Systems Recalled for Incorrect Ejection Fraction Calculations

    Philips is recalling EPIQ 7 ultrasound systems because specific software plug-ins may calculate incorrect ejection fractions, potentially leading to misdiagnosis or incorrect therapy.

    Product
    EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPIC 7C, EPIQ 7W; Catalog Number: 795200 / 795201 and Part Number: 989605386721. Diagnostic Ultrasound Imaging.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0808-2015·2014-12-24

    Siemens Biograph mCT Flow 40-4R Recalled for Display Freeze Risk

    Siemens Medical Solutions is recalling one Biograph mCT Flow 40-4R scanner due to a potential display freeze during CT interventional procedures.

    Product
    Biograph mCT Flow 40-4R, System Material Number 10529159. The Siemens Biograph mCT 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
    2 states
  • HighFDA (Devices)·Z-0451-2015·2014-12-24

    GE Healthcare Recalls Innova IGS 540 Imaging Systems Due to Motion Loss

    GE Healthcare is recalling 10 Innova IGS 540 systems because they may lose real-time imaging or gantry motion due to electromagnetic sensitivity.

    Product
    Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0754-2015·2014-12-24

    Stryker Johann Forceps Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling Johann Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM X 45CM INSERT, JOHANN FORCEPS, P/N 0250080764 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2015·2014-12-24

    Varian On-Board Imager X-ray Generators Recalled for Missing Ground Wire

    Varian Medical Systems is recalling 32 On-Board Imager systems because the X-ray generators are missing a required ground wire.

    Product
    Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land¿¿ marks.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0453-2015·2014-12-24

    GE Healthcare Recalls Innova 4100IQ Fluoroscopic Imaging Systems

    GE Healthcare is recalling six Innova 4100IQ fluoroscopic systems due to a defect that may cause loss of real-time imaging or gantry motion.

    Product
    Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0829-2015·2014-12-24

    Mako Surgical Recalls RESTORIS PST Acetabular Straight Shell Impactors

    Mako Surgical Corporation is recalling 404 RESTORIS PST Acetabular Straight Shell Impactors due to the potential for intraoperative damage.

    Product
    RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2015·2014-12-24

    Siemens Biograph mCT Flow Edge-4R Recalled for Display Freeze Risk

    Siemens Medical Solutions USA Inc. is recalling four Biograph mCT Flow Edge-4R scanners due to a potential system display freeze during CT interventional procedures.

    Product
    Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT 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
    2 states
  • HighFDA (Devices)·Z-0825-2015·2014-12-24

    DePuy Ceramic Femoral Head Recalled for Fit Issues in Hip Surgery

    DePuy Orthopaedics is recalling 19 units of BIOLOX delta TS Ceramic Femoral Heads due to reports that the device did not fit as expected during hip surgery.

    Product
    Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0815-2015·2014-12-24

    Philips QLAB Software Recall for Incorrect Ejection Fraction Calculations

    Philips Ultrasound is recalling QLAB software versions 10.0, 10.1, and 10.1.1 because automated quantification features may report inaccurate cardiac measurements, potentially leading to misdiagnosis.

    Product
    Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field…
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0236-2015·2014-12-24

    Philips Brilliance iCT Computed Tomography System Software Defect Recall

    Philips Medical Systems is recalling 16 Brilliance iCT Computed Tomography X-Ray Systems due to a software defect that may prevent scans from terminating at the intended location.

    Product
    Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0805-2015·2014-12-24

    AMS Monarc Subfascial Hammock Kits Recalled for Packaging Integrity Concerns

    American Medical Systems is recalling Monarc + and Monarc C Subfascial Hammock kits because routine testing showed the sterile packaging might fail during extreme shipping.

    Product
    AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0800-2015·2014-12-24

    Carestream DRX-Revolution Mobile X-Ray System Recalled for Broken Bolts

    Carestream Health is recalling 629 DRX-Revolution Mobile X-Ray Systems because bolts securing the x-ray tube assembly may break, posing a risk of equipment failure.

    Product
    DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2015·2014-12-24

    Stryker Spine Recalls Specialty Audible Torque Wrench Due to Fracture

    Stryker Spine is recalling 15 units of the Specialty Audible Torque Wrench (Lot 4279) after a customer reported the device fractured during surgery.

    Product
    Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0508-2015·2014-12-24

    Philips MobileDiagnost wDR Recalled for Unintended Radiation Exposure Risk

    Philips Medical Systems is recalling MobileDiagnost wDR units due to a potential for unintended radiation exposure during start-up.

    Product
    Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0801-2015·2014-12-24

    Siemens Recalls Turbo Troponin I Diagnostic Kits for Potential Diagnostic Errors

    Siemens Healthcare Diagnostics is recalling 3,622 Turbo Troponin I kits used to diagnose heart attacks due to a Class II safety concern.

    Product
    Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0830-2015·2014-12-24

    Mako Surgical Recalls RESTORIS PST Acetabular Offset Shell Impactors

    Mako Surgical Corporation is recalling 404 RESTORIS PST Acetabular Offset Shell Impactors because they may be damaged during surgery.

    Product
    RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0777-2015·2014-12-24

    Stryker Laparoscopic Scissors Recalled for Sterilization Parameter Errors

    Stryker Endoscopy is recalling 180,573 laparoscopic hook scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, HOOK SCISSORS, 29CM, P/N 0250282049 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0810-2015·2014-12-24

    Siemens Biograph mCT Scanners Recalled for Potential Display Freeze

    Siemens Medical Solutions is recalling eight Biograph mCT S(64)-4R scanners due to a risk of system display freeze during CT interventional procedures.

    Product
    Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biograph mCT 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
    2 states
  • HighFDA (Devices)·Z-0809-2015·2014-12-24

    Siemens Biograph mCT X-4R Recalled for Potential Display Freeze During Procedures

    Siemens Medical Solutions is recalling eight Biograph mCT X-4R scanners due to a possibility of system display freeze during CT interventional procedures.

    Product
    Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT 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
    2 states
  • HighFDA (Devices)·Z-0811-2015·2014-12-24

    Siemens Biograph mCT S(40)-4R Recalled for Display Freeze Risk

    Siemens Medical Solutions is recalling eight Biograph mCT S(40)-4R scanners due to a potential system display freeze during CT interventional procedures.

    Product
    Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biograph mCT 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
    2 states