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

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

28801–28825 of 40357

  • ModerateFDA (Devices)·Z-0136-2017·2016-10-26

    Hand Biomechanics Lab Recalls Agee WristJack Fracture Reduction Systems

    Hand Biomechanics Lab Inc is recalling 65 Agee WristJack Fracture Reduction Systems because a molded beam is slightly larger than optimal, which may make surgical adjustments difficult.

    Product
    Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0112-2017·2016-10-26

    Stryker Recalls Sagittal Blades Due to Potential Sterile Barrier Breach

    Stryker Instruments is voluntarily recalling 225 Sagittal Blades due to a potential sterile barrier breach in the packaging.

    Product
    Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder and ankle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0092-2017·2016-10-26

    Ortho VITROS URIC Slides Recalled Due to NAC Interference

    Ortho-Clinical Diagnostics is recalling VITROS URIC Slides because N-Acetylcysteine (NAC) can interfere with the assay results.

    Product
    VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0128-2017·2016-10-26

    BD Biosciences Recalls Contaminated CD79b PE Antibody Reagent

    Becton, Dickinson and Company is recalling 14 units of CD79b PE antibody reagent due to contamination with a FITC conjugate of unknown specificity.

    Product
    CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0130-2017·2016-10-26

    ConMed Recalls CORE Suction Irrigation Handpieces Due to Packaging Seal Defects

    ConMed Corporation is recalling CORE Suction Irrigation Handpieces because packaging seal creases may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0089-2017·2016-10-26

    Ortho VITROS Chemistry GLU Slides Recalled for Potential Assay Interference

    Ortho-Clinical Diagnostics is recalling VITROS GLU Slides because certain substances, including N-Acetylcysteine, may interfere with glucose measurements.

    Product
    VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0093-2017·2016-10-26

    Tearscience Recalls LipiFlow Thermal Pulsation System Activators Due to Error Condition

    Tearscience, Inc. is recalling 1,200 LipiFlow Thermal Pulsation System Activators because the device may automatically stop treatment during patient use.

    Product
    LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic…
    Category
    Medical Device
    Distribution
    29 states
  • LowFDA (Devices)·Z-0113-2017·2016-10-26

    Osteogenics Recalls Cytoplast Membrane Due to Packaging Error

    Osteogenics Biomedical, Inc. is recalling 32 boxes of Cytoplast Titanium-Reinforced Posterior Singles Membrane because the device may be packaged in the wrong product box.

    Product
    Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.
    Category
    Medical Device
    Distribution
    0 states
  • 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