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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22101–22125 of 40299

  • ModerateFDA (Devices)·Z-0133-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 12 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0138-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 34 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0168-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 10 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0114-2019·2018-10-24

    Siemens ADVIA Centaur CKMB Calibrator Recalled for Potential Bias

    Siemens Healthcare Diagnostics is recalling 69 kits of ADVIA Centaur CKMB Calibrator 2-pack Japan due to a potential bias identified compared to internal standards.

    Product
    ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0182-2019·2018-10-24

    OriGen Dual Lumen Cannula Recalled for Manufacturing Deficiencies

    OriGen Biomedical is recalling 169 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length markings.

    Product
    Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0140-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect

    Zimmer Biomet is recalling 22 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number 814313280 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0162-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0124-2019·2018-10-24

    Affixus Hip Fracture Nails Recalled Due to Compromised Sterile Packaging

    The FDA is recalling 72 Affixus Hip Fracture Nails because sterile packaging was found open during surgery, creating a potential contamination risk.

    Product
    Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0189-2019·2018-10-24

    Siemens Recalls Atellica Sample Handler Prime Software Due to Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica Sample Handler Prime software versions 1.13 and lower due to five identified behavioral issues affecting diagnostic testing.

    Product
    Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0161-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 44 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.

    Product
    Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0127-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 24 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0172-2019·2018-10-24

    Life Technologies Recalls Gibco DPBS Due to Leaky Bottle Caps

    Life Technologies is recalling 240 units of Gibco DPBS due to defective bottle caps that compromise sterility.

    Product
    Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0123-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect

    Zimmer Biomet is recalling 24 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0115-2019·2018-10-24

    Siemens ADVIA Centaur CKMB Master Curve Material Recalled for Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur CKMB Master Curve Material due to a potential bias identified when compared to internal standards.

    Product
    ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0146-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 78 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0153-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 68 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and two foreign countries.

    Product
    Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0121-2019·2018-10-24

    CryoLife Pulmonary Hemi-Artery Graft Recalled for Labeling Error

    CryoLife, Inc. is recalling one CryoPatch SG Pulmonary Hemi-Artery graft because the conduit and branch lengths were switched on the product labeling.

    Product
    CryoPatch SG Pulmonary Hemi-Artery, 1 graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0163-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 50 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.

    Product
    Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0130-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0107-2019·2018-10-24

    Baxter Spectrum IQ Infusion System Recalled for Programming Error

    Baxter is recalling Spectrum IQ Infusion Systems because a software error prevents operators from programming certain infusions.

    Product
    SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0165-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 14 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0180-2019·2018-10-24

    OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Deficiencies

    OriGen Biomedical is recalling 452 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and incorrect tip length markings.

    Product
    Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0132-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 27 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0194-2019·2018-10-24

    Siemens Atellica Analyzer Software Recall for Diagnostic Errors

    Siemens is recalling Atellica Solution software version 1.13 and lower due to five behavioral issues that may cause incorrect test results or sample handling errors.

    Product
    Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0106-2019·2018-10-24

    Helena Laboratories Recalls Mislabeled Protein S ELISA Antigen Kits

    Helena Laboratories is recalling three Protein S ELISA Antigen Kits because internal components were mislabeled, causing the Substrate and Protein S Conjugate to be swapped.

    Product
    "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 mL Protein S Conjugate Solution, 1 x 60mL Sample Diluent…
    Category
    Medical Device
    Distribution
    0 states