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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32601–32625 of 40449

  • ModerateFDA (Devices)·Z-2124-2015·2015-07-29

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 63 WIZARD2 gamma counters worldwide due to a barcode label error that may produce erroneous results.

    Product
    Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2168-2015·2015-07-29

    American Medical Systems Recalls Fiber Stripper Due to Sterilization Validation Issues

    American Medical Systems is recalling Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Fiber Stripper, 550¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2155-2015·2015-07-29

    Cochlear Nucleus Sterile Silicone Template Recalled for Expiration

    Cochlear Americas is recalling 26 units of Nucleus Sterile Silicone Templates because expired product was distributed to specific US states.

    Product
    Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2104-2015·2015-07-29

    Allergan Recalls Natrelle Tissue Expanders for Expired Shelf Life

    Allergan is recalling Natrelle CUI Series Tissue Expanders because the shipped products were beyond their shelf life. The recall involves 23 units total, with 16 distributed in the US.

    Product
    Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2180-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Cleaning Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2158-2015·2015-07-29

    FDA Recalls Sureflex 273 Lithotripsy Fibers Due to Cleaning Validation Issues

    American Medical Systems is recalling Sureflex 273 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Sureflex 273 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2164-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Fiber Stripper, 150¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2130-2015·2015-07-29

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 179 WIZARD2 gamma counters because a barcode label error may produce erroneous results.

    Product
    Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2159-2015·2015-07-29

    FDA Recalls Sureflex 365 Lithotripsy Fibers Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Sureflex 365 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Sureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2185-2015·2015-07-29

    FDA Recalls Disposable Fiber Strippers Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2125-2015·2015-07-29

    Perkinelmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 53 WIZARD2 gamma counters because a barcode label error may produce erroneous results.

    Product
    WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2186-2015·2015-07-29

    FDA Recalls American Medical Systems Fiber Strippers for Validation Issues

    American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet new FDA guidance for reusable products.

    Product
    Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2201-2015·2015-07-29

    Myoscience iovera Smart Tip Recalled for Incorrect Expiration Date Labeling

    Myoscience Inc. is recalling iovera 155 Smart Tips because the expiration dates on the outer boxes and pouches are incorrect.

    Product
    iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2192-2015·2015-07-29

    Hardy Diagnostics Recalls HardyCHROM VRE Agar Due to Lack of Clearance

    Hardy Diagnostics is recalling HardyCHROM VRE Agar because it lacks FDA 510(k) clearance. The product was distributed to one customer in South Carolina.

    Product
    HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2060-2015·2015-07-22

    Zimmer Recalls ZNN Antegrade Femoral Nail Due to Potential Denting

    Zimmer, Inc. is recalling eight ZNN Antegrade Femoral Nail units because a single distributed unit may have been dented, posing a risk of implant fatigue.

    Product
    ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2063-2015·2015-07-22

    Elekta MOSAIQ Oncology Software Recalled for Incorrect Stereotactic Field Size

    Elekta is recalling MOSAIQ Oncology Information System software due to a defect that sends incorrect field sizes to treatment machines for stereotactic plans using cones.

    Product
    MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-2085-2015·2015-07-22

    ViewRay Patient Handling System Software Recalled for Unexpected Movement

    ViewRay is recalling three units of Patient Handling System software due to a report of the couch moving unexpectedly into the bore after a reboot.

    Product
    Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2082-2015·2015-07-22

    FDA Recalls Autopen Classic Automatic Insulin Delivery Pens Due to Dial Defect

    Owen Mumford USA is recalling Autopen Classic Automatic insulin delivery pens because the dose dial fails to stay set, preventing patients from administering their medication.

    Product
    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2015·2015-07-22

    Breas Vivo 50 Home Care Ventilator Recalled for Keypad Malfunction

    Breas Medical AB is recalling 846 Vivo 50 Home Care Ventilators because a keypad malfunction can cause the device to stop treatment without an alarm.

    Product
    Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2064-2015·2015-07-22

    Omnilife Apex ARC Hip Stem Recalled for Sterile Pouch Breach Risk

    Omnilife Science Inc. is recalling 146 Apex ARC Hip Stems because the sterile packaging may breach during shipping or handling.

    Product
    Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2077-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA is recalling 21 Sorin Stockert Heater-Cooler 3T units due to the potential for organism colonization, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2081-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA is recalling 131 Stockert Heater-Cooler 3T units due to potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2015·2015-07-22

    Biomet Recalls A.L.P.S. Medium Bone Plate Forceps Due to Assembly Error

    Biomet is recalling 223 units of A.L.P.S. Medium Bone Plate Forceps because they were assembled with incorrect grip arm tips, potentially preventing surgeons from clamping plates to bone.

    Product
    A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2083-2015·2015-07-22

    Maquet Recalls FLOW-i Anesthesia System Modules Due to Suction Failure

    Maquet is recalling 104 FLOW-i Anesthesia System Auxiliary O2 and Suction Modules because the suction function may not activate or be controlled by the switch.

    Product
    The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2015·2015-07-22

    Eizo RadiForce RX850 Medical Monitors Recalled for Display Abnormalities

    Eizo is recalling RadiForce RX850 medical monitors because they may display images abnormally when connected to specific graphics boards using DisplayPort.

    Product
    RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying and viewing digital images those of digital mammography for review and analysis by trained medical practitioners.
    Category
    Medical Device
    Distribution
    Distributed nationwide