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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25001–25025 of 27686

  • HighFDA (Devices)·Z-1782-2014·2014-06-18

    Cooper Surgical Tampa Catheter Recalled for Potential Sterility Compromise

    CooperSurgical is recalling 1,180 units of the Tampa Catheter because unsealed pouches may compromise the device's sterility.

    Product
    Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2014·2014-06-18

    BioDerm Skin Wipes Recalled for Potential Bacterial Contamination

    BioDerm, Inc. is voluntarily recalling skin-prep wipes used with external male catheters due to potential bacterial contamination.

    Product
    BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2014·2014-06-18

    Philips IntellVue Info Center Patient Monitor Recall for Reboot Loop

    Philips is recalling IntellVue Info Center monitors because a software defect causes reboot loops that interrupt patient monitoring.

    Product
    Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1715-2014·2014-06-11

    Stryker NAV3i Platform Power Boxes Recalled for Missing Electrical Insulation

    Stryker is recalling 20 NAV3i Platform Power Boxes because they may lack electrical insulation on soldering joints, posing a shock hazard.

    Product
    The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical…
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1706-2014·2014-06-11

    GE Healthcare Recalls Kenex Ceiling Suspended Radiation Shields and Lamps

    GE Healthcare is recalling Kenex ceiling suspended radiation shields and surgical lamps due to improper installation. A reported incident involved a shield falling from the ceiling.

    Product
    Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1719-2014·2014-06-11

    ConMed Recalls MACROLYTE Premie Dispersive Electrodes Due to Sparking and Burning

    ConMed Corporation is recalling MACROLYTE Premie Dispersive Electrodes due to confirmed complaints of sparking, no output, and burning at the cord set connection.

    Product
    MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1714-2014·2014-06-11

    Toshiba Infinix X-Ray System Recalled for Table Movement Safety Issue

    Toshiba is recalling two Infinix X-Ray Interventional Systems because the table may continue moving during longitudinal tilt despite error signals.

    Product
    Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1718-2014·2014-06-11

    Intuitive Surgical da Vinci Patient Side Cart Recall for Torque Wrench Calibration

    Intuitive Surgical is recalling two da Vinci Patient Side Cart assemblies because torque wrenches used to tighten bolts were out of calibration, potentially causing system faults or mechanical issues.

    Product
    Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1712-2014·2014-06-11

    Microport Recalls PATH Thread Cup Adaptors Due to Removal Difficulty

    Microport Orthopedics is recalling 140 units of PATH Thread Cup Adaptors because they may be difficult to remove from the impaction handle during surgery.

    Product
    PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2014·2014-06-11

    Hologic Selenia Mammography System Recalled for Defective Emergency Off Switch

    Hologic is recalling 11 Selenia Full Field Digital Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.

    Product
    Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1721-2014·2014-06-11

    Siemens CT Systems Recalled Due to Rubber Damper Degradation Risk

    Siemens Medical Solutions is recalling 345 CT systems because a rubber damper may degrade and break, potentially causing motor mounting plates to loosen and injuring operators or patients.

    Product
    Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1716-2014·2014-06-11

    Stryker NAV3i Platform Power Box Recalled for Missing Electrical Insulation

    Stryker is recalling 20 NAV3i Platform Power Boxes that may lack electrical insulation on soldering joints, posing a risk of electric shock.

    Product
    The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1699-2014·2014-06-11

    Cochlear Baha Soft Tissue Gauge Recalled for Metal Surface Imperfections

    Cochlear Americas Inc. is recalling 288 Baha Soft Tissue Gauges due to manufacturing imperfections that could leave residual metal on patient skin.

    Product
    Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1713-2014·2014-06-11

    Arrow Percutaneous Sheath Introducer Kits Recalled for Dilator Tip Damage

    Arrow International Inc is recalling specific Percutaneous Sheath Introducer Kits due to dilator tip damage that could cause vessel injury.

    Product
    Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2014·2014-06-11

    Hospira Infusion Pumps Recalled for Door Roller Assembly Defect

    Hospira is recalling specific Plum XL and Micro Macro infusion pumps because a door roller assembly may break, preventing the cassette from locking properly.

    Product
    Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2014·2014-06-11

    FDA Recalls Bard Ventralight ST Mesh Due to Potential Sterility Compromise

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1723-2014·2014-06-11

    Medtronic Ascenda Intrathecal Catheter Recalled for Endotoxin Contamination

    Medtronic is recalling Model 8780 Ascenda Intrathecal Catheters because they may contain endotoxin levels exceeding USP limits.

    Product
    Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1678-2014·2014-06-11

    Philips IntelliSpace Portal Software Recall for SPECT Reconstruction Errors

    Philips Medical Systems is recalling IntelliSpace Portal software because SPECT reconstructions may lack scatter correction or apply resolution recovery incorrectly.

    Product
    IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2014·2014-06-11

    Siemens AXIOM Luminos dRFsystem Recalled for Electrostatic Discharge Risk

    Siemens is recalling 37 AXIOM Luminos dRF diagnostic imaging systems because electrostatic discharges may trigger unintended movement, posing a danger to patients and personnel.

    Product
    AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1694-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterility Compromise

    Davol, Inc. is recalling Bard Ventralight ST Mesh because the sterile inflation assembly pouch may be open or have a weak seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2014·2014-06-11

    Hospira Recalls LifeCare 5000 Infusion Pumps Due to Door Roller Defect

    Hospira is recalling LifeCare 5000 infusion pumps because a broken door roller pin may prevent the door from locking the cassette properly, potentially causing alarms or false occlusions.

    Product
    LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1722-2014·2014-06-11

    Philips CT Scanners Recalled for Disengaged Service Latch

    Philips Medical Systems is recalling 6,839 CT scanners worldwide because a service latch may disengage, causing the table top to become free-floating.

    Product
    Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1679-2014·2014-06-11

    Cincinnati Sub-Zero Recalls 115 V Blanketrol II Hyper-Hypothermia Systems

    Cincinnati Sub-Zero is recalling seven 115 V Blanketrol II Hyper-Hypothermia Systems due to an incorrect voltage component that may prevent the device from maintaining patient temperature during cooling.

    Product
    115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1701-2014·2014-06-11

    Hologic M-IV Mammography System Recalled for Defective Emergency Off Switch

    Hologic is recalling three M-IV Mammography Systems because a defective relay switch may prevent the emergency off switch from working, posing a risk of patient injury.

    Product
    Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1673-2014·2014-06-11

    Bayer Medrad Continuum MR Infusion System Recall for Damaged Locking Pins

    Bayer is recalling non-wireless Medrad Continuum MR Infusion Systems shipped before March 2008 due to potentially damaged locking pins in the bracket.

    Product
    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately…
    Category
    Medical Device
    Distribution
    Distributed nationwide