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.

Filters

Agency

Category

Minimum severity

Clear filters

26726–26750 of 27722

  • HighFDA (Devices)·Z-0972-2013·2013-03-27

    DePuy ReClaim Reamer Extension Recalled Due to Broken Tabs

    DePuy Orthopaedics is recalling 750 ReClaim Reamer Extension devices because tabs may break and remain in patients during surgery.

    Product
    ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0962-2013·2013-03-27

    DePuy Spine Recalls Cement Mixer Kits Due to Jamming Risk

    DePuy Spine is recalling CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus kits because the cement mixer may jam or fail to turn properly during surgery.

    Product
    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0959-2013·2013-03-27

    Allen Medical Systems Recalls Traction Boots Due to Assembly Defect

    Allen Medical Systems is recalling 24 traction boots because incorrect assembly could cause the boot to detach, allowing a patient's leg to fall during surgery.

    Product
    Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0954-2013·2013-03-27

    Biomet Spine Polaris Screw Inserter Recalled for Tip Failure Risk

    Ebi, LLC is recalling 59 units of the Biomet Spine Polaris 5.5 Button Lock Screw Inserter due to an increased risk of failure at the driver tip during use.

    Product
    Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0960-2013·2013-03-27

    DePuy Confidence Spinal Cement Mixer Recall for Jamming Defect

    DePuy Spine is recalling the Confidence Spinal Cement System 5cc Kit because the cement mixer may not turn properly and may jam or get stuck during surgery.

    Product
    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0969-2013·2013-03-27

    Molded Products Recalls Sterile Hemodialysis Line Sets Due to Leaks

    Molded Products Inc is recalling 1,200 sterile access and return line sets used in hemodialysis because they leak at the connection site.

    Product
    Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0945-2013·2013-03-20

    Philips CT Systems Recalled for Patient Table Brake Malfunction

    Philips is recalling 4,797 CT systems because a vertical brake malfunction caused an unexpected downward movement of the patient table.

    Product
    Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0940-2013·2013-03-20

    Symbios GOPump Elastometric Infusion PumpKit Recalled for Flow Restrictor Displacement

    Symbios Medical Products is recalling 458 GOPump Elastometric Infusion PumpKits because a flow restrictor bead may become displaced, permitting fast flow of contents.

    Product
    GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0928-2013·2013-03-20

    Sorin Isoline Implantable Defibrillation Leads Recalled for Insulation Breach

    Sorin Group USA is recalling 1,376 Isoline implantable defibrillation leads due to potential internal insulation breaches. The leads are used for treating life-threatening heart arrhythmias.

    Product
    Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0939-2013·2013-03-20

    Draeger Infinity Acute Care System Recall for Inaccurate Blood Pressure Readings

    Draeger Medical is recalling 260 Infinity Acute Care System monitoring units because liquid ingress in the cable can cause inaccurate invasive blood pressure measurements.

    Product
    Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0934-2013·2013-03-20

    GE Healthcare Recalls Cardiovascular X-ray Systems Due to Exposed Wires

    GE Healthcare is recalling 48 Innova IQ cardiovascular X-ray systems because exposed high-voltage wires inside the cabinet pose a shock hazard.

    Product
    GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0931-2013·2013-03-20

    Elekta Synergy XVI Radiation Therapy Imager Recalled for DICOM Tag Defect

    Elekta, Inc. is recalling 164 Synergy XVI Radiation Therapy Digital Imagers because DICOM tags lack sufficient information to identify volumes with the same name.

    Product
    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2013·2013-03-20

    Natus Neurology Recalls Nicolet EEG Wireless Amplifiers Due to Overheating Risk

    Natus Neurology is recalling 114 Nicolet EEG Wireless Amplifiers because they may overheat near the on/off button, posing a risk of discomfort or burns.

    Product
    Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0949-2013·2013-03-20

    Hill-Rom TotalCare SpO2RT2 Bed Recalled for Software Pressure Issue

    Hill-Rom is recalling 309 TotalCare SpO2RT2 beds due to a software defect that may reduce surface cushion pressure, potentially increasing the risk of skin irritation for high-risk patients.

    Product
    TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0920-2013·2013-03-20

    Integra CUSA CEM Nosecone Recalled for Potential Tip Erosion

    Integra LifeSciences is recalling CEM Nosecones for the CUSA EXcel system due to a potential for tip erosion and breakage. No patient injuries have been reported.

    Product
    Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0926-2013·2013-03-20

    Medtronic O-arm Imaging System Recalled for Braking System Failure

    Medtronic is recalling 463 O-arm Imaging Systems worldwide due to a potential failure of the braking system controlling vertical gantry movement.

    Product
    Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2013·2013-03-20

    Genesys Orthopedic Recalls 3.75mm Fixed Cervical Screws Due to Manufacturing Residue

    Genesys Orthopedic Systems is recalling 3.75mm x 12mm Fixed Cervical Screws because manufacturing residue may be present. The residue poses risks of infection, delayed fusion, or revision surgery.

    Product
    3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2013·2013-03-20

    GE Healthcare Recalls Cardiovascular X-ray Systems Due to Locking Nut Issue

    GE Healthcare is recalling specific cardiovascular X-ray imaging systems because a locking nut on the overhead video monitor suspension might loosen.

    Product
    GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0930-2013·2013-03-20

    Siemens ACUSON S2000 ABVS Scanner Recalled for Sharp Transducer Edges

    Siemens is recalling 214 ACUSON S2000 ABVS systems because the transducer pod may contain sharp edges that could cause injury.

    Product
    ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0919-2013·2013-03-20

    Stryker Howmedica Command Instrument Broach Handle Recalled for Fracture Risk

    Stryker Howmedica is recalling 48 Command Instrument Broach Handles used in hip surgery due to reports of handle fracture and component disassociation.

    Product
    Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0892-2013·2013-03-13

    Ad-Tech Macro Micro Subdural Electrodes Recalled for Sharp Edges

    Ad-Tech Medical Instrument Corporation is recalling Macro Micro Subdural Electrodes because they may have sharp edges or fracture, posing a risk of injury to brain tissue.

    Product
    Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0907-2013·2013-03-13

    Siemens ARTISTE syngo RT Therapist software recall for beam delivery error

    Siemens is recalling 5 ARTISTE digital linear accelerators due to a software defect that may cause repeated delivery of radiation beams.

    Product
    SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0901-2013·2013-03-13

    GE Healthcare Recalls Advantage Workstation Volume Viewer Software

    GE Healthcare is recalling Advantage Workstation Volume Viewer software due to potential safety issues that may result in incorrect views and measurements.

    Product
    GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast…
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0908-2013·2013-03-13

    Medtronic DPL Single Stage Venous Cannula Recalled for Rough Metal Edges

    Medtronic is recalling DPL Single Stage Venous Cannulas used in cardiopulmonary bypass due to potential rough metal edges on the tip side ports.

    Product
    Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2013·2013-03-13

    Ethicon PSX PROXIMATE Skin Staple Extractor Recalled for Sterility Concerns

    Ethicon Endo-Surgery is recalling PSX PROXIMATE Skin Staple Extractors because packaging damage may have compromised the sterility of the devices.

    Product
    PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
    Category
    Medical Device
    Distribution
    49 states