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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27851–27875 of 40357

  • SevereFDA (Devices)·Z-0977-2017·2017-01-25

    BioMerieux NucliSENS magnetic extraction reagents recalled for performance drift

    BioMerieux SA is recalling NucliSENS magnetic extraction reagents because a performance drift was observed in BK virus testing for certain silica batches.

    Product
    NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extraction of total nucleic acids from biological specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1026-2017·2017-01-25

    Fresenius 2008T Hemodialysis System Recalled for Software Error

    Fresenius Medical Care is recalling 2008T Series Hemodialysis Systems because a software error may cause the machine to execute a cancelled ultrafiltration rate instead of the displayed rate.

    Product
    Fresenius 2008T Series Hemodialysis System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0950-2017·2017-01-25

    CareFusion Recalls Alaris Pump Modules Due to False Air-in-Line Alarms

    CareFusion is recalling Alaris Pump Modules and AIL sensor kits because false Air-in-Line alarms can interrupt medication infusions.

    Product
    Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0969-2017·2017-01-25

    Bard Halo One Introducer Sheath Recalled for Separation and Kinking

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

    Product
    Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • ModerateFDA (Devices)·Z-1031-2017·2017-01-25

    Exactech Recalls Polyethylene Acetabular Liners Due to Incorrect GTIN Labels

    Exactech, Inc. is recalling 12 polyethylene acetabular liners because they were labeled with incorrect Global Trade Item Numbers (GTINs).

    Product
    AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1025-2017·2017-01-25

    Zimmer Biomet Recalls ArComXL Polyethylene Bearings Due to Labeling Mismatch

    Zimmer Biomet is recalling 19 ArComXL Polyethylene Bearings because packaging labels did not match the physical product inside, posing a risk of surgical delay.

    Product
    Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1032-2017·2017-01-25

    Exactech Recalls Alteon Neck Preserving Stems Due to Incorrect GTIN Labels

    Exactech is recalling 98 Alteon Neck Preserving Stems because they were labeled with incorrect Global Trade Item Numbers (GTINs) that identify them as different devices.

    Product
    Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1023-2017·2017-01-25

    Medacta M.U.S.T. Rods Recalled for Damaged Packaging and Sterility Issues

    Medacta USA Inc. is recalling 82 M.U.S.T. Rods due to damaged packaging and lack of sterility assurance. The recall covers units distributed in the US and several international countries.

    Product
    Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1039-2017·2017-01-25

    Endologix AFX Endovascular AAA System Instructions for Use Update

    Endologix is updating the Instructions for Use and implementing modifications to the AFX Endovascular AAA System.

    Product
    AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1038-2017·2017-01-25

    Endologix AFX Endovascular AAA System Instructions for Use Update

    Endologix updated the Instructions for Use for the AFX Endovascular AAA System to address endoleak Type IIIB.

    Product
    AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1055-2017·2017-01-25

    Binding Site Digital RID Plate Reader Recalled for Software Defect

    The Binding Site Group is recalling Digital RID Plate Readers and software because a defect may prevent the system from flagging out-of-range quality control results.

    Product
    Digital RID Plate Reader and Software Product Code: AD400
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1050-2017·2017-01-25

    Binding Site Freelite Human Lambda Free SPAPlus Kit Recalled for Calibration Drift

    The Binding Site Group is recalling 1,002 units of the Freelite Human Lambda Free SPAPlus Kit because calibration curve activity increased over time.

    Product
    Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1049-2017·2017-01-25

    Endologix AFX2 Endovascular AAA System Recall for Updated Endoleak Information

    Endologix is recalling the AFX2 Endovascular AAA System to provide updated information regarding Type III endoleak rates and patient surveillance.

    Product
    AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 BEA28-100/I16-40 F00820-08 BEA28-80/I16-40 F00820-09 BEA28-60/I16-40 F00820-16…
    Category
    Medical Device
    Distribution
    Distributed nationwide