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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30176–30200 of 40449

  • HighFDA (Devices)·Z-1762-2016·2016-06-01

    American Surgical Cotton Balls Recalled Due to Packaging Sterility Defect

    American Surgical Company is recalling 7 boxes of non-strung cotton balls due to packaging defects that compromise sterility. The affected lots were distributed worldwide.

    Product
    American Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1724-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defect

    American Surgical Company is recalling Americot Blue sponges because defective packaging may compromise sterility. The recall affects 262 boxes distributed worldwide.

    Product
    American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

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

    Product
    Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1723-2016·2016-06-01

    American Surgical Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling Americot Blue sponges because defective packaging may compromise sterility. The recall covers 54 cases distributed worldwide.

    Product
    American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1771-2016·2016-06-01

    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 209 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2016·2016-06-01

    GE Healthcare Discovery IGS 740 Systems Recalled for Image Loss

    GE Medical Systems is recalling 25 Discovery IGS 740 systems due to potential non-recoverable loss of image acquisition during procedures.

    Product
    GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2016·2016-06-01

    American Surgical Delicot-J Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 27 boxes of Delicot-J sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1748-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall covers products distributed in the US and 20 other countries.

    Product
    American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1727-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defects

    American Surgical Company is recalling 33 boxes of Americot Blue sponges because defective packaging may compromise sterility.

    Product
    American Surgical Americot Blue 1/2" x 3" Ref Number: 20-07S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1737-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 11 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Ultracot 5 mm x 8 mm (Glassine) Ref Number: 23-01G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1797-2016·2016-06-01

    American Surgical Uniqcot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 15 cases distributed worldwide.

    Product
    American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1722-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 689 boxes of Delicot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1788-2016·2016-06-01

    American Surgical Delicot-J Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 33 boxes of Delicot-J sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1814-2016·2016-06-01

    Biomet PerFuse Decompression Instrument Recall Due to Missing Parts

    Biomet, Inc. is recalling 22 PerFuse Decompression Instruments because missing Trocar and Plunger Assemblies could delay surgery by more than 30 minutes.

    Product
    PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
    Category
    Medical Device
    Distribution
    5 states
  • 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