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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23401–23425 of 27663

  • HighFDA (Devices)·Z-1774-2015·2015-06-17

    Philips FORTE UPS Accessory Devices Recalled for Battery Acid Leakage Risk

    Philips Medical Systems is recalling 10 FORTE Uninterruptible Power Supply (UPS) accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2015·2015-06-17

    Biomet Recalls Unilateral External Fixation Ankle Clamps Due to Assembly Error

    Biomet, Inc. is recalling 19 unilateral external fixation ankle clamps because they were assembled incorrectly. The defect may prevent full range of motion and cause the pin to loosen from the bone.

    Product
    Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1711-2015·2015-06-10

    Synthes Cannulated Drill Bits Recalled for Potential Breakage During Use

    Synthes, Inc. is recalling specific lots of Cannulated Drill Bits because they have the potential to break during use. The affected devices were distributed in the US and Canada.

    Product
    3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1637-2015·2015-06-10

    Synovis Recalls Vascu-Guard Patches Due to Surface Identification Issues

    Synovis is recalling specific Vascu-Guard Peripheral Vascular Patch codes because users reported difficulty distinguishing the smooth from the rough surface.

    Product
    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1696-2015·2015-06-10

    Zimmer Recalls PRI Femoral Impactor Blocks Due to Adhesive Leak Risk

    Zimmer, Inc. is recalling 1,689 PRI Femoral Impactor Blocks because uncured adhesive may leak from the device, potentially causing a biological response in patients.

    Product
    PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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
  • HighFDA (Devices)·Z-1677-2015·2015-06-03

    Alere i Influenza A & B kits recalled for false negative risk

    Alere Scarborough, Inc. is recalling specific lots of Alere i Influenza A & B kits due to a high invalid rate and increased risk of false negative results.

    Product
    Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1649-2015·2015-06-03

    Philips Brilliance CT 64 Systems Recalled for Unexpected Couch Descent

    Philips is recalling 153 Brilliance CT 64 systems because the patient couch may unexpectedly descend during an exam.

    Product
    Brilliance CT 64. 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-1665-2015·2015-06-03

    United Surgical Associates Recalls Elastic Knee Supports for Missing Latex Label

    United Surgical Associates is recalling 1,260 Elastic Knee Supports because they lack a caution label regarding latex content, posing a risk of allergic skin reactions.

    Product
    Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1653-2015·2015-06-03

    Philips Brilliance CT 16 Air Recalled for Unexpected Couch Descent

    Philips is recalling 153 Brilliance CT 16 Air systems because the patient couch may unexpectedly descend to its lowest point during an exam.

    Product
    Brilliance CT 16 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