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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33001–33025 of 40449

  • HighFDA (Devices)·Z-1712-2015·2015-06-10

    Elekta Oncentra Brachy software recalled for incorrect dose calculation errors

    Elekta, Inc. is recalling Oncentra Brachy radiation therapy planning software because it may calculate incorrect doses for specific regions of interest.

    Product
    Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1704-2015·2015-06-10

    Siemens syngo Workflow SLR Recalled for Potential Order Loss

    Siemens Medical Solutions USA is recalling 131 syngo Workflow SLR systems because a software defect may cause order loss during restarts, leading to diagnosis delays.

    Product
    syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration. The system electronically displays stores, retrieves…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2015·2015-06-10

    Siemens Dade Actin Activated Cephaloplastin Reagent Recalled for Out-of-Range Results

    Siemens Healthcare Diagnostics is recalling Dade Actin Activated Cephaloplastin Reagent because assay controls are out of assigned ranges, potentially causing inaccurate APTT test results.

    Product
    Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring an activated partial thromboplastin reagent.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1694-2015·2015-06-10

    Zimmer Recalls 4.5mm Cortical Screws for M/DN Intramedullary Nail System

    Zimmer, Inc. is recalling 4.5mm Cortical Screws for the M/DN system because they are not compatible with the device, potentially causing surgical complications.

    Product
    Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2015·2015-06-10

    Alcon Custom Pak Recalled for Potential Glove Splits and Holes

    Alcon Research, Ltd. is recalling Alcon Custom Paks because the Devon Light Glove component may have splits or holes, which could lead to surgical site infections.

    Product
    The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1700-2015·2015-06-10

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Heparin Activity Failure

    Edwards Lifesciences is recalling 978 Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters because they failed internal statistical tests for heparin activity.

    Product
    Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1708-2015·2015-06-10

    Siemens Dimension Vista LOCI TSH Test Recalled for Inaccurate Results

    Siemens is recalling 2,256 units of the Dimension Vista LOCI TSH test due to a defect that may cause falsely low results.

    Product
    Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1705-2015·2015-06-10

    Siemens Medical Software Recall for Missing Image Measurements on Printouts

    Siemens Medical Solutions is recalling 167 units of Syngo.via and Syngo.x software because measurements on subsequent images do not appear on printouts.

    Product
    Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1710-2015·2015-06-10

    Nidek EC-5000 Excimer Laser System Recalled for Unapproved Manual Feature

    Nidek Inc is recalling 114 EC-5000 Excimer Laser Corneal Surgery Systems because the multi-stage treatment option in the operator's manual was not approved by the FDA.

    Product
    EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1697-2015·2015-06-10

    Coreva Recalls ActCel Hemostatic Dressing for Unapproved Marketing Claims

    Coreva Health Science is recalling ActCel Hemostatic Dressing because customer literature and websites promoted unapproved uses for controlling bleeding in body cavities.

    Product
    ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose For Bleeding Control For external topical and temporary use only Sterility of contents guaranteed unless individual envelope is…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1692-2015·2015-06-10

    Smiths Medical Recalls BCI Advisor Vital Signs Monitors for Data Errors

    Smiths Medical is recalling 15 BCI Advisor Vital Signs Monitors because their auxiliary serial ports may transmit incorrect data to collection systems.

    Product
    Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1713-2015·2015-06-10

    Siemens Factor IX Plasma Reagent Recalled for Inaccurate Low-Range Results

    Siemens Healthcare Diagnostics is recalling Factor IX plasma reagents for the BCS/BCS XP system due to erroneously high results at the lower end of the measuring range.

    Product
    Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1709-2015·2015-06-10

    AMUSA Recalls 0.9% Sodium Chloride Flush Syringes Due to Incorrect Expiration Date

    MRP, LLC dba AMUSA is recalling 200,000 units of 0.9% Sodium Chloride Injection Flush Syringes because the labels display an incorrect expiration date.

    Product
    0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-1707-2015·2015-06-10

    Ortho-Clinical Diagnostics Recalls VITROS Signal Reagent Due to Labeling Defects

    Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products Signal Reagent, Lot 3082, because the reagent packs may contain blank labels.

    Product
    VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1650-2015·2015-06-03

    Philips Brilliance CT 40 Recalled Due to Unexpected Couch Descent

    Philips Medical Systems is recalling 153 Brilliance CT 40 systems because the patient couch may unexpectedly descend to its lowest point during an exam.

    Product
    Brilliance CT 40. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1609-2015·2015-06-03

    CareFusion AVEA Ventilator Recalled for Pressure Transducer Failure

    CareFusion is recalling AVEA ventilators because a pressure transducer failure can stop ventilation. Nonbreathing patients may require manual ventilation or a different device.

    Product
    CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2015·2015-06-03

    Biosense Webster Recalls SMARTABLATE RF Generator Systems Due to Unintended Energy Delivery

    Biosense Webster is recalling 115 SMARTABLATE RF Generator Systems because two complaints reported the device inadvertently delivered RF energy during procedures.

    Product
    SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1655-2015·2015-06-03

    Philips Brilliance CT 6 Air Systems Recalled for Unexpected Couch Descent

    Philips is recalling 153 Brilliance CT 6 Air systems because the patient couch unexpectedly descended during exams. The units were distributed in China.

    Product
    Brilliance CT 6 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1652-2015·2015-06-03

    Philips Brilliance CT 16 Water Computed Tomography Systems Recalled for Couch Descent

    Philips Medical Systems is recalling 153 Brilliance CT 16 Water systems because the patient couch may unexpectedly descend during an exam.

    Product
    Brilliance CT 16 Water. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1688-2015·2015-06-03

    Terumo Advanced Perfusion System 1 Base Recalled for Power Loss

    Terumo is recalling 1,713 Advanced Perfusion System 1 bases worldwide to address power loss issues. The recall involves design changes and switch protectors.

    Product
    Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2015·2015-06-03

    Halyard KimVent Closed Suction System Recalled for Potential Valve Defect

    Halyard Health is recalling specific KimVent Turbo-Cleaning Closed Suction Systems for adults because a defective internal valve may allow air to leak from the ventilator circuit.

    Product
    KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece (Product Code 227135).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2015·2015-06-03

    Codman 3000 Series Refill Set Recalled for Leaking Needles

    Codman & Shurtleff, Inc. is recalling 5,463 units of the CODMAN 3000 Series Refill Set because the needles may leak from the hub connection.

    Product
    CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1681-2015·2015-06-03

    Medtronic Recalls SynchroMed II Implantable Pumps Due to Alarm Failure

    Medtronic is recalling specific SynchroMed II implantable drug pumps because the audible alarm may stop working, potentially preventing patients from detecting issues.

    Product
    Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted…
    Category
    Medical Device
    Distribution
    Distributed nationwide