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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30101–30125 of 40325

  • ModerateFDA (Devices)·Z-1712-2016·2016-06-01

    RayStation Therapy Treatment Planning Software Recalled for Synchronization Bug

    RaySearch Laboratories is recalling RayStation Therapy Treatment Planning System software due to a bug that can cause views to become unsynchronized with stored data.

    Product
    RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-1720-2016·2016-06-01

    Accriva APTT Cuvettes Recalled Due to Mis-positioned Reagent

    Accriva Diagnostics is recalling APTT Cuvettes for the Hemochron Jr. system because the clot activating reagent may be mis-positioned or absent, causing test errors or high results.

    Product
    Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1710-2016·2016-06-01

    Synthes 3.2 mm Radiolucent Drill Bits Recalled for Sterile Packaging Compromise

    Synthes (USA) Products LLC is recalling 1,274 sterile 3.2 mm radiolucent drill bits because the protective cap may not be secured, risking puncture of the sterile barrier.

    Product
    3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1704-2016·2016-06-01

    Leica Calretinin Antibody Recalled for Reduced Staining Performance

    Leica Microsystems is recalling Novocastra Calretinin antibodies because they may show reduced staining when used with specific diluent lots.

    Product
    Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1708-2016·2016-06-01

    Stryker Recalls Mislabeled Reprocessed Diagnostic Electrophysiology Catheters

    Stryker Sustainability Solutions is recalling 18 reprocessed diagnostic electrophysiology catheters because they were mislabeled for size.

    Product
    Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1790-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling 338 boxes of Delicot sponges because defective packaging compromises sterility. The products were distributed worldwide.

    Product
    American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1813-2016·2016-06-01

    Volcano Cardiology Imaging Systems Recalled for Network Compatibility Reboot Issue

    Volcano Corporation is recalling specific cardiology imaging systems due to a software incompatibility that can cause unexpected reboots when encountering specific hospital network data.

    Product
    Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1709-2016·2016-06-01

    Synthes 3.2 mm Drill Bits Recalled for Sterile Packaging Compromise

    Synthes (USA) Products LLC is recalling 7,363 sterile 3.2 mm three-fluted drill bits because the protective cap may not be secured, allowing the tip to puncture the sterile barrier.

    Product
    3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1705-2016·2016-06-01

    Elekta iGUIDE System Software Recall for Radiotherapy Positioning Errors

    Elekta, Inc. is recalling 20 iGUIDE Systems due to a software issue that may allow pre-treatment imaging to be performed before the HexaPOD is in the correct position.

    Product
    iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1830-2016·2016-06-01

    Roche Recalls Hungarian Instructions for cobas EGFR Mutation Test Kits

    Roche is recalling 8 kits of cobas EGFR Mutation Test v2 and cfDNA Sample Preparation due to errors in the Hungarian translated instructions for use.

    Product
    cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1614-2016·2016-05-25

    Monteris Medical Recalls NeuroBlate Laser Probes Due to Lens Fracture

    Monteris Medical Corp is recalling 121 NeuroBlate System SideFire Select 2.2 mm Directional Laser Probes because a sapphire lens fractured during a procedure, introducing CO2 into a patient's brain.

    Product
    NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01. NeuroBlate System SideFire Select Directional Laser Probes are part of the NeuroBlate System. The Monteris…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1680-2016·2016-05-25

    Zimmer Herbert Cannulated Bone Screw Recall for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling specific lots of Herbert Cannulated Bone Screws because a small hole may be present in the inner tray, potentially compromising sterility.

    Product
    Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 90 mm Length 47115509007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1677-2016·2016-05-25

    Zimmer Manufacturing Recalls Sterile Hip and Trauma Implant Screws

    Zimmer Manufacturing B.V. is recalling specific lots of sterile Hip and Trauma Implant Screws because a small hole may be present in the inner tray.

    Product
    Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 4.0 mm Cancellous Screw Fully Threaded, 18 mm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2016·2016-05-25

    Zimmer Manufacturing Recalls Sterile Hip and Trauma Implant Screws

    Zimmer Manufacturing B.V. is recalling specific lots of sterile Hip and Trauma Implant Screws because a small hole may be present in the inner tray.

    Product
    M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2016·2016-05-25

    Becton Dickinson Recalls Shielded IV Catheters Due to Defect

    Becton Dickinson is recalling 1.3 million shielded IV catheters because a defect could cause the catheter to separate or break.

    Product
    1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer catalog number 381700 2) 24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded IV catheter (0.7 mm x 14 mm) made of FEP polymer catalog number 381720
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1672-2016·2016-05-25

    Medtronic Recalls Visualase Cooled Laser Applicator Systems Due to Melting Risk

    Medtronic is recalling 120 Visualase Cooled Laser Applicator Systems because the catheters may melt during procedures.

    Product
    Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1673-2016·2016-05-25

    Zimmer 3.5 mm Cortical Screws Recalled for Potential Sterility Compromise

    Zimmer Manufacturing B.V. is recalling specific lots of 3.5 mm Cortical Screws because a small hole may be present in the inner tray, potentially compromising sterility.

    Product
    Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw SelfTapping, 16 mm Length 47483501601 3.5 mm Cortical Screw SelfTapping, 24 mm Length 47483502401…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1692-2016·2016-05-25

    Alcon Valved Entry System Recalled for Potential Leakage

    Alcon Research, Ltd. is recalling 83,448 units of 23G and 25G Valved Entry Systems because they may leak beyond design specifications.

    Product
    Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1688-2016·2016-05-25

    Alcon Recalls LenSx Lasers Due to Incomplete Corneal Flap Creation

    Alcon is voluntarily recalling 81 LenSx Laser Systems with Corneal Flap Capability due to reports of incomplete corneal flap creation during surgery.

    Product
    LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1682-2016·2016-05-25

    Zimmer VersaFx Femoral Fixation System Screws Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling specific lots of VersaFx Femoral Fixation System screws because a small hole may be present in the inner tray, potentially compromising sterility.

    Product
    VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2016·2016-05-25

    Zimmer Manufacturing Recalls Specific Lots of Sterile Hip and Trauma Implant Screws

    Zimmer Manufacturing B.V. is recalling 99 units of sterile Hip and Trauma Implant Screws due to a potential small hole in the inner tray.

    Product
    Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1694-2016·2016-05-25

    Alcon Recalls 23G and 25G Valved Trocar Cannula Custom Paks

    Alcon Research, Ltd. is recalling 30,701 units of 23G and 25G valved trocar cannula Custom Paks because the products have the potential to leak beyond their design specification.

    Product
    Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1669-2016·2016-05-25

    Lumenis M22 IPL Acne Filters Recalled for Superficial Burn Risk

    Lumenis Ltd is recalling M22 IPL Acne Filters due to a risk of superficial burns when using the device.

    Product
    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1693-2016·2016-05-25

    Alcon Recalls 23G and 25G Constellation Totalplus Paks for Potential Leakage

    Alcon Research, Ltd. is recalling 225,000 units of 23G and 25G Constellation Totalplus Paks because the products have the potential to leak beyond their design specifications.

    Product
    23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1671-2016·2016-05-25

    AB Sciex Mass Spectrometers Recalled for Incorrect Quantitative Results

    AB Sciex is recalling two models of mass spectrometers used for in vitro diagnostics because they may report incorrect quantitative results under certain conditions.

    Product
    AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    1 state