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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Minimum severity

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

Clear filters

32526–32550 of 40325

  • 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
  • HighFDA (Devices)·Z-2058-2015·2015-07-22

    Biomet Recalls 50 A.L.P.S. Cortical Locking Screws Due to Packaging Defect

    Biomet, Inc. is recalling 50 A.L.P.S. 3.5mm x 60 mm Cortical Locking Screws because the sterile packaging was not sealed, posing a risk of infection.

    Product
    A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2079-2015·2015-07-22

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

    Sorin Group USA is recalling 28 Sorin Stockert Heater-Cooler 3T devices due to potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2015·2015-07-22

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

    Sorin Group USA, Inc. is recalling 2,837 Sorin 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, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2015·2015-07-22

    Stryker Woundcare Replacement Kits Recalled for Potential Sterility Breach

    Stryker is recalling Woundcare Replacement Kits used for wound debridement due to a potential sterility breach in the packaging.

    Product
    0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2093-2015·2015-07-22

    Northern Digital recalls disposable reflective marker spheres for surgical tracking

    Northern Digital Inc. is recalling 32,400 disposable reflective marker spheres used in Brainlab IGS systems due to inadequate adhesive curing that may cause the spheres to separate.

    Product
    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2059-2015·2015-07-22

    Exactech Spine Set Screw Recalled for Incorrect Thread Form

    Exactech, Inc. is recalling 749 Altiva Large Set Screws due to incorrect thread form. The devices were distributed in six states.

    Product
    Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2073-2015·2015-07-22

    Etac Supporter toilet armrest recalled due to loose fasteners

    Etac Supply Center Ab is recalling 25 units of Supporter toilet armrests because fasteners may come loose, causing the product to become unsteady.

    Product
    Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2078-2015·2015-07-22

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

    Sorin Group USA is recalling 283 Sorin Stockert Heater-Cooler 3T units due to potential colonization of organisms, including Mycobacteria, if proper disinfection is not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2095-2015·2015-07-22

    Alere i Influenza A & B Kit Recalled for False Negative Risk

    Alere is recalling 257 kits of the Alere i Influenza A & B test due to microbial growth that may cause false negative results.

    Product
    Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2084-2015·2015-07-22

    NDI Disposable Reflective Marker Spheres Recalled for Adhesive Defect

    Northern Digital Inc. is recalling NDI Disposable Reflective Marker Spheres because inadequate adhesive curing may cause the spheres to separate.

    Product
    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2092-2015·2015-07-22

    Synthes Recalls RIA Drive Shafts and Reamer Heads Due to Breakage Risk

    Synthes, Inc. is recalling Reamer / Irrigator / Aspirator (RIA) components because they may break if incorrectly assembled or used improperly.

    Product
    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2080-2015·2015-07-22

    Sorin Heater-Cooler Devices Recalled for Potential Microbial Colonization

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

    Product
    Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2065-2015·2015-07-22

    Biomet Oxford Femoral Drill Guide Recalled for Undersized Diameter

    Biomet is recalling 18 Oxford Femoral Drill Guide Lateral IM Adapters because an undersized diameter may interfere with a specific IM Link component.

    Product
    Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. Partial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2088-2015·2015-07-22

    Eizo RadiForce RX650 LCD Monitor Recalled for Display Abnormalities

    Eizo is recalling RadiForce RX650 LCD monitors that may display abnormally when connected to specific graphics boards using DisplayPort.

    Product
    RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2061-2015·2015-07-22

    Agfa Healthcare Recalls Two IMPAX Agility Medical Imaging Systems

    Agfa Healthcare is recalling two IMPAX Agility PACS units in Missouri due to a software error that displayed incorrect patient names.

    Product
    IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2070-2015·2015-07-22

    Exactech Recalls Four Ambassador Cervical Plate Systems

    Exactech, Inc. is recalling four Ambassador Cervical Plate Systems that were shipped to a single consignee in Florida before final inspection was completed.

    Product
    Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2067-2015·2015-07-22

    Nidek Green Laser Photocoagulator Accessories Recalled for Missing Labels

    Nidek Inc is recalling 22 units of GYC-1000 laser accessories because they are missing required Laser Aperture labels.

    Product
    Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
    Category
    Medical Device
    Distribution
    14 states