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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32976–33000 of 40449

  • HighFDA (Devices)·Z-1722-2015·2015-06-17

    Vilex FUZE Ankle Arthrodesis Screws Recalled for Breakage

    Vilex, Inc. is recalling FUZE 10.0 mm x 200 mm ankle arthrodesis screws because the incidence of breakage is higher than expected.

    Product
    Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1714-2015·2015-06-17

    ASP Recalls EVOTECH Endoscope Cleaner for Connection Detection Failure

    Advanced Sterilization Products is recalling EVOTECH Endoscope Cleaner and Reprocessor units because they may fail to detect disconnected endoscopes, allowing the cleaning cycle to complete without proper processing.

    Product
    EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1763-2015·2015-06-17

    Philips Brilliance CT 40 Uninterruptible Power Supply Recall

    Philips is recalling Brilliance CT 40 Uninterruptible Power Supply accessories due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1788-2015·2015-06-17

    Philips Recalls GEMINI TF Ready UPS Accessory Devices for CT Systems

    Philips Medical Systems is recalling three GEMINI TF Ready UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fumes.

    Product
    GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1758-2015·2015-06-17

    Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device Recalled for Potential Damage

    Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to potential damage near the hub that may cause blood leakage.

    Product
    Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1719-2015·2015-06-17

    Elekta Recalls Leksell GammaPlan Software Due to Memory Corruption

    Elekta is recalling 10 units of Leksell GammaPlan 10.2 software because memory can become corrupted when creating a fused study via drag and drop.

    Product
    Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1768-2015·2015-06-17

    Philips Brilliance iCT UPS Accessory Devices Recalled for Battery Acid Leakage

    Philips Medical Systems is recalling Brilliance iCT UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2015·2015-06-17

    Philips FORTE UPS Accessory Devices Recalled for Battery Acid Leakage Risk

    Philips Medical Systems is recalling 10 FORTE Uninterruptible Power Supply (UPS) accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2015·2015-06-17

    Biomet Recalls Unilateral External Fixation Ankle Clamps Due to Assembly Error

    Biomet, Inc. is recalling 19 unilateral external fixation ankle clamps because they were assembled incorrectly. The defect may prevent full range of motion and cause the pin to loosen from the bone.

    Product
    Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1725-2015·2015-06-17

    Abbott Alkaline Wash Recall Due to Cap Leaking and Crystallization

    Abbott Laboratories is recalling Alkaline Wash cleaning solution for Abbott Architect analyzers due to product leaking from the cap and crystallization around the cap.

    Product
    Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1718-2015·2015-06-17

    Advanced Back Technologies Recalls Extentrac Elite User Manual

    Advanced Back Technologies is recalling 18 Extentrac Elite User Manuals because they incorrectly state the device is for patients up to 350 lbs, while the device is only approved for up to 300 lbs.

    Product
    Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1749-2015·2015-06-17

    Orthofix Firebird Spinal Fixation System Recalled for Mislabeling

    Orthofix is recalling Firebird Spinal Fixation System screws because the length marking on the tip is incorrect.

    Product
    ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1638-2015·2015-06-17

    GE OEC Brivo 865 Plus Mobile X-ray Laser Aimer Assemblies Recalled

    GE OEC Medical Systems is recalling nine mobile X-ray laser aimer assemblies because they were shipped without required laser product certification.

    Product
    GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1729-2015·2015-06-17

    Ortho-Clinical Diagnostics Recalls VITROS Urine Assay Data Disks

    Ortho-Clinical Diagnostics is recalling VITROS Urine Assay Data Disks because a software error may allow samples requiring acidified pretreatment to be metered from the same container as those requiring no pretreatment.

    Product
    Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1717-2015·2015-06-17

    Extentrac Elite Powered Decompression Table Recalled for Weight Limit Mislabeling

    Advanced Back Technologies is recalling 36 Extentrac Elite powered decompression tables because the product brochure incorrectly states a 350-lb weight limit, while the device is only approved for patients up to 300 lbs.

    Product
    Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1746-2015·2015-06-17

    Becton Dickinson Recalls BBL Port A Cul Tubes Due to Oxidation

    Becton Dickinson is recalling BBL Port A Cul tubes because excessive oxidation may affect the viability of anaerobic microorganisms.

    Product
    BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1720-2015·2015-06-17

    Roscoe Mini Neb Compressor User Manual Recall for Warning Updates

    Compass Health Brands is recalling 219,353 Roscoe Mini Neb Compressor user manuals to add warnings about proper handling and storage to reduce power cord damage.

    Product
    Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1754-2015·2015-06-17

    Biomet Recalls Hip Components Due to Incorrect GTIN Labeling Codes

    Biomet is recalling specific hip joint replacement components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.

    Product
    Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1755-2015·2015-06-17

    Biomet Shoulder Joint Replacement Components Recalled for Incorrect GTIN Codes

    Biomet, Inc. is recalling specific shoulder joint replacement components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.

    Product
    Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1740-2015·2015-06-17

    Acclarent Recalls Expired RELIEVA FLEX Sinus Guide Catheter Units

    Acclarent, Inc. is recalling 986 RELIEVA FLEX Sinus Guide Catheter units distributed in Texas because one unit was found to be past its expiry date.

    Product
    RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1756-2015·2015-06-17

    Biomet Knee Joint Replacement Components Recalled for Incorrect GTIN Codes

    Biomet is recalling MCK Maximum Congruent Knee System components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.

    Product
    MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1757-2015·2015-06-17

    Biomet Recalls Hip Joint Components Due to Incorrect GTIN Labeling

    Biomet is recalling 1,315 hip joint replacement components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.

    Product
    Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1711-2015·2015-06-10

    Synthes Cannulated Drill Bits Recalled for Potential Breakage During Use

    Synthes, Inc. is recalling specific lots of Cannulated Drill Bits because they have the potential to break during use. The affected devices were distributed in the US and Canada.

    Product
    3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1637-2015·2015-06-10

    Synovis Recalls Vascu-Guard Patches Due to Surface Identification Issues

    Synovis is recalling specific Vascu-Guard Peripheral Vascular Patch codes because users reported difficulty distinguishing the smooth from the rough surface.

    Product
    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1696-2015·2015-06-10

    Zimmer Recalls PRI Femoral Impactor Blocks Due to Adhesive Leak Risk

    Zimmer, Inc. is recalling 1,689 PRI Femoral Impactor Blocks because uncured adhesive may leak from the device, potentially causing a biological response in patients.

    Product
    PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide