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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29976–30000 of 40325

  • ModerateFDA (Devices)·Z-1834-2016·2016-06-08

    MicroAire Pneumatic Impactor Recall for Missing Symbol Markings

    MicroAire is recalling 20 Pneumatic Impactor units because they are missing required lock and unlock symbol markings.

    Product
    Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1874-2016·2016-06-08

    Philips Ingenuity Core 128 CT Systems Recalled for Drive Mapping Issue

    Philips Medical Systems is recalling 424 Ingenuity Core 128 CT systems because the system may not map the Varian drive after a user logout and login.

    Product
    Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1875-2016·2016-06-08

    Philips Ingenuity CT Systems Recalled for Drive Mapping Issue

    Philips is recalling 215 Ingenuity CT systems because they may fail to map the Varian drive after a user logs out and back in.

    Product
    Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1900-2016·2016-06-08

    Exactech Recalls Three Ceramic Hip Acetabular Cups Due to Premature Packaging

    Exactech is recalling three Novation Ceramic AHS Cluster-Hole Shells because they were packaged before the required site-change approval was granted.

    Product
    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1839-2016·2016-06-08

    Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues

    Baxter Healthcare is recalling 6,804 units of COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.

    Product
    COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1877-2016·2016-06-08

    Leica Microsystems Recalls Unstable CDX2 Antibody Lots

    Leica Microsystems is recalling specific lots of Novocastr CDX2 antibody because testing showed they are not stable until their expiration dates.

    Product
    Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1902-2016·2016-06-08

    Exactech Recalls Four Novation Femoral Stems Due to Premature Packaging

    Exactech is recalling four Novation femoral stems because they were packaged before the required site-change approval was granted.

    Product
    Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-1909-2016·2016-06-08

    Affymetrix Recalls CytoScan Dx Assay Kits Due to Missing Warning Statements

    Affymetrix is recalling 507 CytoScan Dx Assay kits because FDA inspectors found that required warning statements were missing from product shipments.

    Product
    CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software: MOD R LA, CytoScan¿ Dx…
    Category
    Medical Device
    Distribution
    15 states
  • LowFDA (Devices)·Z-1907-2016·2016-06-08

    B. Braun Recalls Non-Vented Dispensing Pins Due to Packaging Tears

    B. Braun Medical is recalling 11,000 Non-Vented Dispensing Pins because the outer blister packaging may tear, potentially compromising the device.

    Product
    Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1906-2016·2016-06-08

    B. Braun Medical Recalls Non-Vented Dispensing Pins Due to Packaging Tears

    B. Braun Medical is recalling approximately 11,000 Non-Vented Dispensing Pins because the outer blister packaging may tear, potentially compromising the product label.

    Product
    Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1759-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 34 boxes of strung cotton balls due to packaging defects that compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1636-2016·2016-06-01

    Hummingbird Med Recalls Hummi Micro Draw Blood Transfer Devices

    Hummingbird Med is recalling Hummi Micro Draw Blood Transfer Devices because the Y connector may separate from the cannula hub during use.

    Product
    ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1792-2016·2016-06-01

    American Surgical Delicot X Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Delicot X sponges due to packaging defects that compromise sterility. The recall covers 3 boxes distributed worldwide.

    Product
    American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1823-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet, Inc. is recalling specific trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1821-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility.

    Product
    Various trauma and sports medicine instruments and implants. Bit, drill.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1780-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling 442 boxes of Delicot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2016·2016-06-01

    AngioVac Circuit Packs Recalled for Excessive Endotoxin Levels

    AngioDynamics is recalling AngioVac Circuit Packs because they may contain RotaFlow Centrifugal Pumps with endotoxin levels exceeding regulatory limits.

    Product
    AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 39 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1829-2016·2016-06-01

    RTI Surgical Recalls Streamline OCT Spinal Fixation Instruments

    RTI Surgical is recalling 17 Streamline OCT Crosslink Counter Torque Sleeves because a defect may obstruct the cannula, potentially causing driver slippage and patient injury.

    Product
    Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1753-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 87 boxes of strung cotton balls due to packaging defects that compromise sterility.

    Product
    American Surgical Cotton Balls-Strung 1/4" Ref Number: 30-00 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2016·2016-06-01

    AngioVac Circuit Recall Due to Potential Endotoxin Levels

    Angiodynamics is recalling Vortex MEDICAL AngioVac Circuits because they may contain endotoxin levels exceeding regulatory limits.

    Product
    Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1706-2016·2016-06-01

    GE Healthcare Discovery IGS 730 Recalled for Potential Image Loss

    GE Medical Systems is recalling 54 Discovery IGS 730 systems due to a risk of non-recoverable loss of image acquisition during procedures.

    Product
    GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 16 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1729-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defects

    American Surgical Company is recalling Americot Blue sponges because defective packaging may compromise sterility. The recall covers 37 boxes distributed worldwide.

    Product
    American Surgical Americot Blue 3/8" x 3/4" Ref Number: 20-14S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1806-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Telfa 1" x 3" sponges because defective packaging compromises sterility. The recall covers 57 boxes distributed worldwide.

    Product
    American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide