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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22001–22025 of 40175

  • ModerateFDA (Devices)·Z-0128-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 19 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 380 mm, Item Number 814309380 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0143-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 10 units of 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 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0110-2019·2018-10-24

    GE Healthcare MRI Systems Recalled for Potential Image Flipping and Data Mismatch

    GE Medical Systems is recalling 5,200 MRI systems with software version 11.x because service activities may have failed to reinstall the latest software, potentially causing flipped images or patient data mismatches.

    Product
    GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL #…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0150-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 33 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The devices were distributed nationwide and in Chile and the Netherlands.

    Product
    Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0117-2019·2018-10-24

    Siemens Atellica IM CKMB Master Curve Material Recalled for Potential Bias

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

    Product
    Atellica IM CKMB Master Curve Material, Cat No. 10995534 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-0158-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 85 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 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0113-2019·2018-10-24

    Siemens Recalls ADVIA Centaur CKMB Calibrator Kits Due to Potential Bias

    Siemens Healthcare Diagnostics is recalling 1,870 ADVIA Centaur CKMB Calibrator kits due to a potential bias compared to internal standards.

    Product
    ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0126-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 51 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Right 125 9 mm x 340 mm, Item Number 814309340 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0142-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling nine 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 125 13 mm x 360 mm, Item Number 814313360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0192-2019·2018-10-24

    Siemens Atellica IM 1300 Analyzer Software Recall for Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version 1.13 and lower due to five identified behavioral issues affecting reagent locks, barcode reading, and result reporting.

    Product
    Atellica IM 1300 Analyzer (SMN 11066001). 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-0151-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect

    Zimmer Biomet is recalling 15 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.

    Product
    Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0136-2019·2018-10-24

    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 11 mm x 440 mm, Item Number 814311440 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0137-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 18 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 11 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0109-2019·2018-10-24

    FDA Recalls Ambu Aura40 Reusable Laryngeal Masks Due to Labeling Error

    Besmed Health Business Corporation is recalling Ambu Aura40 Standard reusable laryngeal masks because they are packaged in pouches marked as single-use.

    Product
    Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0167-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect

    Zimmer Biomet is recalling 16 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 11 mm x 400 mm, Item Number 814611400 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0176-2019·2018-10-24

    Terumo Advanced Perfusion System 1 Electronic Patient Gas System Recall

    Terumo is recalling 152 Advanced Perfusion System 1 Electronic Patient Gas Systems because the service manual was not updated for software version 1.30.

    Product
    Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0119-2019·2018-10-24

    Cypress Medical Recalls McKesson Insulin Syringes Due to Suction Defect

    Cypress Medical Products LLC is recalling 400 cases of McKesson Insulin Syringes because a small hole impedes liquid suction.

    Product
    McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0169-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect

    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 125 9 mm x 165 mm, Item Number 816709165 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0145-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 16 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 9 mm x 260 mm, Item Number 814409260 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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