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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19951–19975 of 40124

  • ModerateFDA (Devices)·Z-2192-2019·2019-08-14

    Philips IQon Spectral CT Recall for Cardiac Image Labeling Error

    Philips is recalling 25 IQon Spectral CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.

    Product
    IQon Spectral CT Model # 728332, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2160-2019·2019-08-14

    Howmedica Serrato Polyaxial Screws Recalled for Incorrect Length

    Howmedica Osteonics Corp. is recalling 11 Serrato polyaxial screws because some 90mm and 100mm units were manufactured with the wrong length.

    Product
    Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2185-2019·2019-08-14

    Ortho VITROS Calibrator Kit 32 Recalled for Software Anomaly

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2189-2019·2019-08-14

    Philips iCT Computed Tomography System Recalled for Image Labeling Error

    Philips is recalling 128 iCT computed tomography systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.

    Product
    iCT, Model # 728306, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2141-2019·2019-08-14

    Biomet 3i Recalls Titanium Dental Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 17 units of Certain Bellatek Titanium Abutments because a manufacturing defect prevents the screw from seating correctly.

    Product
    CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2198-2019·2019-08-14

    Siemens Lantis System Recalled for Windows RDP Vulnerability

    Siemens Medical Solutions is recalling Lantis systems due to a Microsoft Windows Remote Desktop Protocol vulnerability.

    Product
    Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2205-2019·2019-08-14

    Philips Azurion X-ray systems recalled for cold restart delays

    Philips is recalling Azurion interventional fluoroscopic X-ray systems because a cold restart may take up to 7 minutes, potentially delaying treatment.

    Product
    Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2208-2019·2019-08-14

    Abbott Recalls Alinity i Ferritin Reagent Kits Due to Manufacturing Defect

    Abbott Ireland Diagnostics Division is recalling 216 units of Alinity i Ferritin Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument failure.

    Product
    Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2197-2019·2019-08-14

    Siemens Lantis Commander Radiation Therapy Software Recalled for RDP Vulnerability

    Siemens Medical Solutions is recalling 15 Lantis Commander units due to a Microsoft Windows Remote Desktop Protocol vulnerability.

    Product
    Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2217-2019·2019-08-14

    MedComp Recalls Hemodialysis Catheter Kits Due to Labeling Error

    Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved.

    Product
    14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2174-2019·2019-08-14

    Ortho VITROS 250 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling 30 VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.

    Product
    VITROS 250 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2146-2019·2019-08-14

    Geistlich Bio-Oss Pen Recalled Due to Visible Plastic Debris

    Geistlich Pharma is recalling Bio-Oss Pen units because visible green plastic debris was found on the outer barrel when unscrewing the cap.

    Product
    Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20116 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2170-2019·2019-08-14

    Centurion Driveline Management System 1 Daily Kit Recalled for Packaging Risk

    Centurion Medical Products is recalling 6,180 Driveline Management System 1 Daily Kits because sterile packaging may be compromised.

    Product
    DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2147-2019·2019-08-14

    Geistlich Bio-Oss Pen Recalled Due to Visible Plastic Debris

    Geistlich Pharma North America is recalling Bio-Oss Pen applicators because a visible piece of green plastic was found on the outer barrel when unscrewing the cap.

    Product
    Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2186-2019·2019-08-14

    Philips Ingenuity CT Recalled for Potential Cardiac Image Labeling Error

    Philips is recalling 92 Ingenuity CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.

    Product
    Ingenuity CT, Model # 728326, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2182-2019·2019-08-14

    Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Anomaly

    Ortho Clinical Diagnostics is recalling nine VITROS 4600 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS 4600 Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2144-2019·2019-08-14

    Biomet 3i Recalls Titanium Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 49 units of Certain Bellatek Titanium Abutments because a manufacturing defect prevents the screw from seating correctly.

    Product
    CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2229-2019·2019-08-14

    Siemens Ferritin Reagent Cartridge Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling 815 Dimension Ferritin Flex reagent cartridges due to negative bias. The affected lot is EA9227.

    Product
    Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human serum and plasma. Measurements of ferritin aid in the…
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-2190-2019·2019-08-14

    Philips iCT SP Computed Tomography Systems Recalled for Image Labeling Error

    Philips is recalling 27 iCT SP computed tomography systems because images may be incorrectly labeled as having phase tolerance applied when it was not.

    Product
    iCT SP Model # 728311, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2184-2019·2019-08-14

    Ortho VITROS 5,1 FS Chemistry System Recalled for Software Calibration Issue

    Ortho Clinical Diagnostics is recalling 55 VITROS 5,1 FS Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.

    Product
    VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2100-2019·2019-08-14

    ASTRA Lidar System Recalled for Incorrect Class 1 Laser Labeling

    ASTRA, LLC is recalling one Lidar System for Erosion Flume Application due to incorrect labeling of a Class 1 laser product.

    Product
    Lidar System for Erosion Flume Application Class 1 Laser Product Product Usage: Product is installed and fixed above a dynamic indoor flume designed for modeling water erosion in an indoor research environment with limited human access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2159-2019·2019-08-14

    DRG Salivary Testosterone ELISA Recalled for Inaccurate Low-Range Results

    DRG Instruments GmbH is recalling 38 kits of Salivary Testosterone ELISA because the assay may report testosterone levels that are too low.

    Product
    DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2150-2019·2019-08-14

    Randox Human Assayed Multi-Sera Level 2 Recalled for Incorrect Control Values

    Randox Laboratories is recalling Human Assayed Multi-Sera Level 2 controls due to incorrectly assigned target and range values for specific analytes.

    Product
    Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2195-2019·2019-08-14

    Siemens Lantis 6.1 Commander Recalled for Windows RDP Vulnerability

    Siemens Medical Solutions is recalling two Lantis 6.1 Commander units due to a Microsoft Windows Remote Desktop Protocol vulnerability.

    Product
    Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient…
    Category
    Medical Device
    Distribution
    10 states