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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30451–30475 of 40325

  • ModerateFDA (Devices)·Z-1361-2016·2016-04-20

    Neurotherm NT2000iX RF Generator Recalled for Uncleared Software Settings

    Neurotherm is recalling 25 NT2000iX RF Generators because they shipped with international software settings enabled, allowing access to modes not cleared for use in the United States.

    Product
    Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1396-2016·2016-04-20

    Bard TruGuide Biopsy Needle Recall Due to Incorrect Stylet Size

    Bard Peripheral Vascular is recalling TruGuide Disposable Coaxial Biopsy Needles because they may contain an incorrectly sized blunt tip stylet that will not pass through the coaxial.

    Product
    Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1392-2016·2016-04-20

    Synthes OPAL Spinal Fusion Cage Recalled for Labeling Mismatch

    Synthes (USA) Products LLC is recalling 6 units of OPAL Spacers because the outer packaging label does not match the product inside or its intended use.

    Product
    Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1497-2016·2016-04-20

    AMT G-Jet Feeding Device Recalled for Length Discrepancy

    Applied Medical Technology is recalling 20 units of G-Jet feeding devices because they are shorter than labeled.

    Product
    AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stomach.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1362-2016·2016-04-20

    US Endovascular Recalls Ebony PTA Catheters Due to Kinking Risk

    US Endovascular is recalling 843 Ebony PTA catheters because they may kink during use, rendering them unusable.

    Product
    USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1354-2016·2016-04-20

    Philips Ingenuity Core CT Systems Recalled for Software Error

    Philips is recalling 88 Ingenuity Core CT systems because a software error may prevent automatic transmission of image data to remote devices.

    Product
    Ingenuity Core Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-1359-2016·2016-04-20

    C.R. Bard Recalls Foley Catheters Due to Labeling Error

    C.R. Bard is recalling 1.4 million latex Foley catheters because the instructions for use list an incorrect inflation volume.

    Product
    BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1352-2016·2016-04-20

    Philips Brilliance iCT CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 324 Brilliance iCT Computed Tomography systems due to a software error that may prevent automatic transmission of image data to remote devices.

    Product
    Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-1358-2016·2016-04-20

    Bard Foley Catheter Recall Due to Incorrect Inflation Volume Labeling

    C.R. Bard is recalling 1.4 million Bardex Foley catheters because the instructions for use list an incorrect inflation volume.

    Product
    BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1350-2016·2016-04-20

    Siemens Recalls One CT System Due to Front Cover Welding Defect

    Siemens is recalling one SOMATOM Definition AS CT system because a front cover weld defect could cause a bolt to break during service, though no clinical risk exists.

    Product
    SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1390-2016·2016-04-20

    BD Retic-Count Reagent System Recalled for Incorrect Storage Labeling

    Becton, Dickinson and Company is recalling one lot of BD Retic-Count Reticulocyte Reagent System because the carton label listed incorrect storage conditions.

    Product
    BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics
    Category
    Medical Device
    Distribution
    10 states
  • CriticalFDA (Devices)·Z-1275-2016·2016-04-13

    FDA Recalls Guardian II Hemostasis Valves Due to Air Embolism Risk

    Vascular Solutions is recalling Guardian II Hemostasis Valves because the low-pressure seal may fail, potentially allowing air into the device and causing an air embolism.

    Product
    Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1272-2016·2016-04-13

    Focus Diagnostics Recalls Simplexa HSV 1&2 Direct Amplification Discs

    Focus Diagnostics is recalling Simplexa HSV 1&2 Direct Amplification Discs because they may cause false negative or positive results and error codes.

    Product
    Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1274-2016·2016-04-13

    Focus Diagnostics Recalls Simplexa Group A Strep Direct Amplification Discs

    Focus Diagnostics is recalling Simplexa Group A Strep Direct Amplification Discs because they may cause false test results or error codes.

    Product
    Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1327-2016·2016-04-13

    Synthes Recalls Titanium Low Profile Neuro Screws Due to Thread Defect

    Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws because the thread height is undersized, potentially compromising the device's structural integrity.

    Product
    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1323-2016·2016-04-13

    MicroAire French Rasp Aspiration Cannula Recalled for Bending or Breaking

    MicroAire Surgical Instruments is recalling 37 units of the PAL-R4011XL French Rasp aspiration cannula because they bent or broke during surgery.

    Product
    MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1315-2016·2016-04-13

    ScottCare TeleSentry Battery Recall Due to Explosion Risk During Recharging

    ScottCare is recalling 9,067 TeleSentry batteries after a complaint that one exploded while recharging. The batteries are used in cardiac monitoring devices.

    Product
    TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation. Intended for diagnostic evaluation of patients who experience transient…
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-1322-2016·2016-04-13

    Therakos CELLEX Photopheresis System Recalled for Tubing Leaks

    Therakos Inc is recalling 729 units of the CELLEX Photopheresis System, Lot D342, due to an increased trend in tubing leaks within the pump tubing organizer.

    Product
    The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI: 20705030200003 The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1343-2016·2016-04-13

    AngioDynamics Recalls NAMIC Convenience Kits Due to Needle Lumen Defect

    AngioDynamics is recalling 136 NAMIC Convenience Kits because the needle inner lumen is too small to accept the intended 0.038-inch guidewire.

    Product
    NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1324-2016·2016-04-13

    Fresenius Hemoflow F3 Dialyzer Recalled for Potential Header Leak

    Fresenius Medical Care is recalling 1,650 Hemoflow F3 Dialyzers due to a potential header leak caused by improper torque.

    Product
    Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1317-2016·2016-04-13

    Philips Recalls eValueMed Infant Heel Warmers and Transport Mattresses

    Philips is recalling eValueMed infant heel warmers and transport mattresses because they lack expiration dates and warnings about overheating risks.

    Product
    eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2016·2016-04-13

    AngioDynamics Recalls Renown Regional Medical Center Convenience Kits

    AngioDynamics is recalling 100 Renown Regional Medical Center Convenience Kits because the needle inner lumen is too small to accept the intended guidewire.

    Product
    NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291 Product Usage - This needle is intended to be placed over the guidewire to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1348-2016·2016-04-13

    Ortho-Clinical VITROS 5600 Integrated System Recalled for Wiring Error

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because a wiring error may leave a module energized when the power cord is unplugged.

    Product
    VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1346-2016·2016-04-13

    AngioDynamics Recalls NAMIC Convenience Kits Due to Needle Lumen Defect

    AngioDynamics is recalling 45 NAMIC Convenience Kits because the needle inner lumen may be too small to accept a 0.038-inch guidewire.

    Product
    NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1316-2016·2016-04-13

    Recall of eValueMed Infant Heel Warmers and Transport Mattresses

    Philips is recalling eValueMed Infant Heel Warmers and Transport Mattresses because they lack expiration dates and warnings about overheating risks after shelf life.

    Product
    evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur
    Category
    Medical Device
    Distribution
    Distributed nationwide