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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26026–26050 of 27686

  • HighFDA (Devices)·Z-2177-2013·2013-09-18

    Leica Surgical Microscope Recall Due to Axis Brake Failure

    Leica Microsystems is recalling 28 surgical microscopes because the Z-axis and/or AB and C-axis brakes failed during installation.

    Product
    Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2161-2013·2013-09-18

    GE Healthcare Recalls Tec 6 Anesthesia Vaporizers Due to Leak Detection Issue

    GE Healthcare is recalling Tec 6 and Tec 6 Plus anesthesia vaporizers because the pre-operative leak test may fail to detect leaks caused by seal wear.

    Product
    Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2183-2013·2013-09-18

    Monoject Heparin Lock Flush Syringes Recalled for Potential Non-Sterile Water

    FDA is recalling Monoject 10 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water while labeled as saline or heparin.

    Product
    Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2171-2013·2013-09-18

    Siemens ADVIA Centaur Folate Reagent Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling 488 units of ADVIA Centaur Folate reagent due to calibration failures and quality control shifts.

    Product
    ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2167-2013·2013-09-18

    Xlumena NAVIX Access Device Recalled for Catheter Fracture Risk

    Xlumena is recalling 148 units of the NAVIX Access Device because a complaint investigation found the catheter can fracture at the distal end under load.

    Product
    Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation…
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2173-2013·2013-09-18

    Roche Recalls cobas 4800 HPV Test Kits Due to Formulation Error

    Roche Molecular Systems is recalling specific lots of cobas 4800 HPV test kits because a formulation error was identified during the manufacture of the Master Mix reagent.

    Product
    KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas¿ HPV Test is a qualitative in vitro test for the detection of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2193-2013·2013-09-18

    CareFusion Recalls Thoracentesis Trays Due to Catheter Occlusion Risk

    CareFusion is recalling Thoracentesis and Safe-T Thoracentesis Trays because the included catheters may occlude, potentially delaying medical procedures and causing patient complications.

    Product
    *** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2169-2013·2013-09-18

    Siemens ADVIA Centaur Folate Test Kits Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate test kits due to calibration failures and significant negative shifts in quality control and patient results.

    Product
    ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2191-2013·2013-09-18

    Lumenis Vision One Laser System Recalled for Unintended Laser Exposure

    Lumenis is recalling three Vision One Laser Systems due to a potential for unintended laser exposure to the user.

    Product
    Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2166-2013·2013-09-18

    B. Braun Recalls Outlook Safety Infusion System Burette Sets

    B. Braun Medical is recalling 900 Outlook Safety Infusion System Burette Sets because one injection site and valve were assembled upside down.

    Product
    Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2145-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers 660 units distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 220 units distributed worldwide.

    Product
    LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2013·2013-09-11

    Stelkast Recalls Distal Femoral Augments Due to Sterility Breach

    Stelkast Co is recalling 11 units of SC2316 Distal Femoral Augments with Screws due to a breach of sterility in the packaging.

    Product
    SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2154-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme is recalling 110 units of LeGoo Endovascular Occlusion Gel 0.5 mL because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.

    Product
    LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2144-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 250 units distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Fiber Particulates

    Genzyme Corporation is recalling 776 units of LeGoo Internal Vessel Occluder because the product contains particulates (fibers). The recall covers units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2152-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Fiber Particulates

    Genzyme is recalling LeGoo Internal Vessel Occluder 5mL units because they contain fiber particulates. The recall covers 308 units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates

    Genzyme is recalling LeGoo Internal Vessel Occluder devices because they contain particulates (fibers). The recall affects 448 units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2158-2013·2013-09-11

    MicroAire Steinmann Pins Recalled Due to Potential Sterility Compromise

    MicroAire Surgical Instruments is recalling Steinmann Pins because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.

    Product
    Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2140-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling 65 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers lots distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2150-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates

    Genzyme Corporation is recalling 652 units of LeGoo Internal Vessel Occluder because the product contains particulates (fibers). The recall covers units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2153-2013·2013-09-11

    Genzyme Recalls LeGoo Internal Vessel Occluder Due to Particulates

    Genzyme Corporation is recalling 37 units of LeGoo Internal Vessel Occluder 10mL because the product contains particulates (fibers). The recall covers units distributed worldwide.

    Product
    LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2159-2013·2013-09-11

    MicroAire Kirschner-Wire Recall Due to Defective Sterile Pouch Seals

    MicroAire Surgical Instruments is recalling Kirschner-Wires because defective pouch seals may compromise sterility. The recall affects 15,786 units distributed worldwide.

    Product
    Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2013·2013-09-11

    DePuy Spine Recalls Confidence Spinal Cement System Kits

    DePuy Spine is recalling Confidence Spinal Cement System Kits because hydraulic pump leaks can cause loss of pressure during cement injection.

    Product
    CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or…
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-2147-2013·2013-09-11

    Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates

    Genzyme Corporation is recalling 181 units of LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.

    Product
    LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the…
    Category
    Medical Device
    Distribution
    Distributed nationwide