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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

20276–20300 of 27647

  • SevereFDA (Devices)·Z-0968-2017·2017-01-25

    Bard Halo One Introducer Sheath Recalled for Separation and Kinking

    Bard Peripheral Vascular is recalling Halo One 5F Introducer Sheaths due to complaints of separation, kinking, and tip damage during use.

    Product
    Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use inperipheral arterial and venous procedures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1027-2017·2017-01-25

    Fresenius 2008K Hemodialysis System Recalled for Software Error

    Fresenius Medical Care is recalling 2008K Series Hemodialysis Systems because a software error may cause the machine to execute a cancelled Ultrafiltration Rate setting.

    Product
    Fresenius 2008K Series : Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0976-2017·2017-01-25

    BioMerieux Recalls MagSIL Magnetic Silica Reagents Due to Performance Drift

    BioMerieux SA is recalling 3,723 units of MagSIL (NucliSENS easyMAG Magnetic Silica) worldwide due to observed performance drift in BK virus testing.

    Product
    MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1029-2017·2017-01-25

    Fresenius 2008K@home Hemodialysis System Recalled for Software Defect

    Fresenius Medical Care is recalling 2008K@home hemodialysis systems because a software error may cause the machine to execute a cancelled ultrafiltration rate.

    Product
    Fresenius 2008K@home Series : Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2017·2017-01-25

    Binding Site Optilite Analyser Recalled for Lid Injury Risk

    The Binding Site Group is recalling 129 Optilite Analyser units because the lid may fall suddenly and cause injury if not fully open.

    Product
    Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1053-2017·2017-01-25

    Freelite Human Lambda Free Kit Recalled for Calibration Curve Error

    The Binding Site Group is recalling Freelite Human Lambda Free Kits due to a calibration curve change that causes an increase in false prozone flags.

    Product
    Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2017·2017-01-25

    Merge Cardio software recalled for potential image loading errors

    Merge Healthcare is recalling Merge Cardio software versions 9.0 through 10.1.2 because a specific user action may cause images to be missing, potentially leading to incorrect diagnosis or treatment.

    Product
    Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1051-2017·2017-01-25

    Great Basin Staph ID/R Blood Culture Panel Recalled for False Positives

    Great Basin Scientific is recalling the Staph ID/R Blood Culture Panel because the S. aureus probe could result in false positive results.

    Product
    Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1056-2017·2017-01-25

    Baxter Peritoneal Dialysis Set Recalled for Reported Leaks

    Baxter Healthcare is recalling 8,640 APD Set with Cassette 3-Prong Peritoneal Dialysis Sets due to customer complaints about leaks.

    Product
    APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1033-2017·2017-01-25

    Meridian Premier EHEC Diagnostic Kits Recalled for False Positive Results

    Meridian Bioscience is recalling Premier EHEC and Premier EHEC Bulk diagnostic kits because internal testing showed they can produce false positive results with some broth specimens.

    Product
    PREMIER EHEC and PREMIER EHEC Bulk.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-1034-2017·2017-01-25

    Ultradent NanoTips 30g Dental Tips Recalled for Loose Cannula

    Ultradent Products, Inc. is recalling NanoTips 30g dental tips because the stainless steel cannula may detach from the base, posing a risk during intra-oral procedures.

    Product
    NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2017·2017-01-25

    Fresenius 2008K2 Hemodialysis System Recalled for Software Error

    Fresenius Medical Care is recalling 2008K2 hemodialysis systems because a software error may cause the machine to execute a cancelled ultrafiltration rate instead of the displayed rate.

    Product
    Fresenius 2008K2 Series : Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1009-2017·2017-01-18

    Elekta Monaco RTP System Recalled for Incorrect Wedge Calculations

    Elekta is recalling 279 Monaco RTP Systems because they may calculate Enhanced Dynamic Wedge or Virtual Wedge values incorrectly.

    Product
    Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0984-2017·2017-01-18

    Medline E-Z Lubricating Jelly Recalled Due to Lack of Sterilization

    Medline is recalling 12,024 tubes of E-Z Lubricating Jelly because they were not sterilized due to a shipping error.

    Product
    Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1008-2017·2017-01-18

    Smith & Nephew Recalls Reflection Dead Blow Mallets Due to Weld Cracks

    Smith & Nephew is recalling Reflection Dead Blow Mallets because cracks in the weld allowed lead beads to escape into surgical wounds.

    Product
    REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1020-2017·2017-01-18

    Stryker Recalls Reunion TSA Peg Alignment Sound Due to Breakage

    Stryker Howmedica Osteonics Corp. is recalling 131 units of the Reunion TSA Peg Alignment Sound because the instrument broke during surgery.

    Product
    Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2017·2017-01-18

    Alcon Monarch III Cartridge Recalled Due to Potential Lens Lodging

    Alcon Research, Ltd. is recalling 1,130 Monarch III (1) "C" Cartridges because the intraocular lens could become lodged within the device.

    Product
    Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0964-2017·2017-01-18

    Stryker Recalls Reprocessed Electrophysiology Catheter Cables Due to Sterility Breach

    Stryker Sustainability Solutions is recalling reprocessed electrophysiology catheter cables because a breach in sterile packaging may have occurred, potentially rendering the product non-sterile.

    Product
    Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The…
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-0987-2017·2017-01-18

    Elekta Oncentra Radiation Therapy Software Recalled for Cross Profile Defect

    Elekta, Inc. is recalling Oncentra External Beam and Brachy software because a cross profile for a Varian 60-degree wedge shows 'horns.' The recall covers 433 units distributed worldwide.

    Product
    Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2017·2017-01-18

    Medtronic MRI-Conditional Cardiac Devices Recalled for Software Feature Error

    Medtronic is recalling 21,111 MRI-conditional cardiac resynchronization therapy devices because the AdaptivCRT feature may appear enabled when it is not active.

    Product
    Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0967-2017·2017-01-18

    C.R. Bard Recalls Medical Devices Containing Latex Catheters

    C.R. Bard is recalling specific medical device trays and stabilization devices because they contained latex catheters instead of silicone catheters.

    Product
    SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-1011-2017·2017-01-18

    Symmetry Surgical ULTRA Sterrad Container Recall for Sealant Defect

    Symmetry Surgical is recalling 149 ULTRA Sterrad containers because deteriorated or missing base trim sealant may allow contaminants to enter the container after sterilization.

    Product
    symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136-SP, C13139-SP, C13854-SP, C13855-SP, C13856-SP, C181310-SP, C18134-SP, C18135-SP, C18136-SP, C18138-SP, C22854-SP, C22855-SP, C22856-SP, C22858-SP, C24134-SP, C24135-SP…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1006-2017·2017-01-18

    Philips IQon Spectral CT Recalled for Image and Scan Errors

    Philips is recalling 35 IQon Spectral CT systems due to software issues causing rescans, incorrect scan locations, or misrepresentation of image results.

    Product
    IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1007-2017·2017-01-18

    Medtronic Recalls AxIEM Touch N Go Pointer Probe for Accuracy Issues

    Medtronic Navigation is voluntarily recalling 111 AxIEM Touch N Go Pointer Probes because they may compromise navigation accuracy during patient registration.

    Product
    AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide