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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20951–20975 of 27682

  • HighFDA (Devices)·Z-0267-2017·2016-10-26

    Windstone Medical Packaging Recalls Surgical Set Up Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 16 surgical Set Up Packs because they may contain defective gloves that compromise sterility.

    Product
    Set Up Pack, Kit number PSS3574(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0255-2017·2016-10-26

    Windstone Medical Recalls Ortho Pack Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 92 Ortho Pack kits because they may contain defective gloves with splits or holes that compromise sterility.

    Product
    Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0284-2017·2016-10-26

    Windstone Medical Packaging Recalls Virginia Custom Pack Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling Virginia Custom Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2017·2016-10-26

    Windstone Medical Custom Surgery Kits Recalled for Sterility Compromise

    Windstone Medical Packaging recalled 56 custom surgery kits because the included Medtronic gloves may contain splits or holes, compromising sterility.

    Product
    Custom Tray, Kit numbers: PSS1836 and PSS1836(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0006-2017·2016-10-19

    HeartWare HVAD Pump Recalled for Foreign Material in Driveline Connector

    HeartWare is recalling 344 HVAD pumps worldwide because foreign material in the driveline connector could cause electrical faults.

    Product
    HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart…
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-0067-2017·2016-10-19

    Brathwaites Oliver Medical Recalls Introes Pocket Bougie Endotracheal Tube Introducers

    Brathwaites Oliver Medical is recalling Introes Pocket Bougie endotracheal tube introducers because the device may break during intubation.

    Product
    The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0080-2017·2016-10-19

    Contour Zero-Gravity Radiation Protection System Recalled for Cable Failure Risk

    Contour Fabricators is recalling 447 Zero-Gravity radiation protection systems because excessive cable rotation may cause the shield to fall, posing an injury risk.

    Product
    Zero-Gravity Radiation Protection System Radiology Personnel protective shield.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2017·2016-10-19

    GE OEC Brivo Mobile C-Arm X-Ray Recall for Uncontrolled Motion

    GE Healthcare is recalling 148 OEC Brivo mobile C-arm X-ray units because a circuit board failure may cause the C-arm to move vertically without command.

    Product
    OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0077-2017·2016-10-19

    Varian Head Frame Posts Recalled Due to Rotation Risk

    Varian Medical Systems is recalling 75 Head Frame Posts because they can rotate easily on the mounting cam. No serious injuries have been reported.

    Product
    Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0073-2017·2016-10-19

    Fujifilm Synapse PACS Software Recalled for Potential Image Data Errors

    Fujifilm Medical Systems is recalling Synapse PACS software versions 4.0 through 4.3 because patient image data may be incorrect.

    Product
    Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0076-2017·2016-10-19

    Elekta Monaco RTP System Recalled for Incorrect Dose Calculation

    Elekta is recalling 365 Monaco RTP Systems because a software error can cause incorrect MU scaling when specific plan parameters are modified.

    Product
    Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose…
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0062-2017·2016-10-19

    Siemens Symbia T Series SPECT + CT Recall for Bearing Failure Risk

    Siemens Medical Solutions is recalling 1,109 Symbia T Series SPECT + CT systems because linear bearing cars may fail, allowing ball bearings to fall out.

    Product
    Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2017·2016-10-19

    Stryker Orthopaedics Recalls Universal Acetabular Cup Positioner/Impactor

    Stryker Howmedica Osteonics Corp. is recalling 3,768 units of the Universal Acetabular Cup Positioner/Impactor because the thread length may protrude past the dome of the acetabular trial or implant.

    Product
    Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0061-2017·2016-10-19

    Siemens Symbia S Camera Systems Recalled for Bearing Failure Risk

    Siemens Medical Solutions is recalling Symbia S camera systems because linear bearing cars may fail, allowing ball bearings to fall out.

    Product
    Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT component is intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0069-2017·2016-10-19

    Cardinal Health Recalls V. Mueller Spinal Distraction Screws Due to Corrosion

    Cardinal Health 200, LLC is recalling V. Mueller Neuro/Spine Shadow-Line Spinal Distraction Screws because corrosion was demonstrated on the screw surface.

    Product
    V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0081-2017·2016-10-19

    Siemens Recalls Rubella IgM Assay Kits Due to False Positive Results

    Siemens is recalling specific lots of Rubella IgM assay kits because they may produce false positive or indeterminate results on certain analyzers.

    Product
    SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2017·2016-10-19

    Siemens Rubella IgM Assay Recalled for False Positive Results

    Siemens is recalling specific lots of Rubella IgM assays due to increased false positive and indeterminate results.

    Product
    SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0070-2017·2016-10-19

    Medtronic O-arm O2 Surgical Imaging System Recalled for Calibration Errors

    Medtronic is recalling 14 O-arm O2 Surgical Imaging Systems because spatial calibration may be erroneous in navigated images, potentially affecting surgical accuracy.

    Product
    Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0085-2017·2016-10-19

    ConMed Recalls HeatWave Electrodes Due to Insulation Damage Risk

    ConMed is recalling specific HeatWave Electrodes because damaged shaft insulation could increase the risk of patient burns during arthroscopic procedures.

    Product
    CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0056-2017·2016-10-19

    Natus Medical Recalls Medix NatalCare LX Incubators Due to Wheel Defect

    Natus Medical is recalling 104 Medix NatalCare LX Intensive Care Incubators because a defective base weld may cause wheels to bend out of alignment.

    Product
    The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0078-2017·2016-10-19

    TheraSphere Y-90 Microspheres Recalled for Incorrect Radioactivity Labeling

    Biocompatibles U.K., Ltd. is recalling one dose of TheraSphere Y-90 Glass Microspheres shipped to Hong Kong because the labeled radioactivity was incorrect.

    Product
    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0074-2017·2016-10-19

    Banyan Medical Pyramidal Trocar Recalled for Potential Sterility Issues

    Banyan Medical is recalling 5 x 55mm Pyramidal Trocars due to a potential lack of assurance of sterility. The affected units were distributed in Indiana and Tennessee.

    Product
    Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0075-2017·2016-10-19

    Banyan Medical Pyramidal Tip Trocar Recalled for Sterility Concerns

    Banyan Medical is recalling 5 x 55mm Pyramidal Tip Trocars due to a potential lack of assurance of sterility. The recall affects 64 boxes distributed in Indiana and Tennessee.

    Product
    Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0007-2017·2016-10-12

    Baxter Recalls 0.2 Micron Filters Due to Missing Membrane

    Baxter Corporation is voluntarily recalling 0.2 Micron Filters because the filter membrane may be missing, allowing particulate matter to pass through.

    Product
    0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
    Category
    Medical Device
    Distribution
    Distributed nationwide