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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30526–30550 of 40449

  • ModerateFDA (Devices)·Z-1356-2016·2016-04-20

    Philips Ingenuity CT Systems Recalled for Software Error in Data Transmission

    Philips Medical Systems is recalling 82 Ingenuity CT systems due to a software error that may prevent the automatic transmission of image data to remote devices.

    Product
    Ingenuity CT 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-1365-2016·2016-04-20

    ICU Medical Recalls Diana Automated Compounding Systems for Accuracy Issues

    ICU Medical is recalling 57 Diana Automated Compounding Systems because they may not accurately mix volumes under 5ml.

    Product
    Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1391-2016·2016-04-20

    X-NAV Recalls X-Guide Surgical Navigation System X-Clip Bulk Kits

    X-NAV Technologies is recalling 845 X-Guide Surgical Navigation System X-Clip Bulk Kits because the stainless steel fiducials may not meet specifications.

    Product
    X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1379-2016·2016-04-20

    Stryker SurgiCounter Scanner Recalled for Software Interaction Errors

    Stryker is recalling 286 SurgiCounter scanners because they may display error messages and fail to display software version numbers correctly in the SC360 application.

    Product
    SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1357-2016·2016-04-20

    Bard Foley Catheter Recalled for 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 3cc Foley Catheter, Rx only. 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-1370-2016·2016-04-20

    Boston Scientific Recalls PT Graphix Magnet J-TIP Guidewires Due to Tip Defect

    Boston Scientific is voluntarily recalling PT Graphix Magnet J-TIP Guidewires because the wires are straight instead of having the pre-formed J-tip.

    Product
    Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H7491490201MJo (UPN referenced on the Pouch Label) . Boston Scientific PT Graphix Magnet Guidewire with ICE Hydrophilic Coating is a steerable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1375-2016·2016-04-20

    Merit Medical Recalls TSX Transseptal Needle Due to Labeling Error

    Merit Medical Systems is recalling one lot of TSX Transseptal Needles because the packaging labels incorrectly state a 50-degree curve instead of the actual 86-degree curve.

    Product
    Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1394-2016·2016-04-20

    Alcon Recalls VERION Reference Units Due to Surgical Plan Errors

    Alcon is voluntarily recalling 97 VERION Reference Units because unplanned arcuate lines may appear on printed or exported surgical plans.

    Product
    VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1378-2016·2016-04-20

    Stryker Recalls Spetzler Claw Tips Due to Incorrect Packaging Assembly

    Stryker is recalling 140 Spetzler Claw Tips because they were packaged with the incorrect size Tip Sleeve Assembly, which may cause surgical delays.

    Product
    Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The Spetzler Claw" Tips are bone cutting tips which are a part of Strykers Neuro Spine Ear, Nose and Throat (ENT) Sonopet Portfolio. They are removable attachments…
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1355-2016·2016-04-20

    Philips Ingenuity Core 128 CT Systems Recalled for Software Error

    Philips is recalling 174 Ingenuity Core 128 CT systems due to a software error that may prevent automatic transmission of image data to remote devices.

    Product
    Ingenuity Core 128 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-1351-2016·2016-04-20

    Philips Brilliance 64 CT Systems Recalled for Software Data Transmission Error

    Philips Medical Systems is recalling 285 Brilliance 64 CT systems because a software error may prevent the automatic transmission of all image and data series to remote devices.

    Product
    Brilliance 64: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-1389-2016·2016-04-20

    Cygnus Medical First Step Bedside ADDWATER Kit Recalled for Foreign Material

    Cygnus Medical is recalling First Step Bedside ADDWATER Kits due to foreign material found in the containers. The recall affects 39 cases distributed to 13 US states.

    Product
    Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1364-2016·2016-04-20

    ICU Medical Recalls Diana Automated Compounding Systems for Accuracy Issues

    ICU Medical is recalling 36 Diana Automated Compounding Systems because they may not meet accuracy specifications when mixing volumes under 5ml.

    Product
    Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1353-2016·2016-04-20

    Philips Brilliance iCT SP CT Systems Recalled for Software Error

    Philips is recalling 49 Brilliance iCT SP CT systems due to a software error that may prevent automatic transmission of image data to remote devices.

    Product
    Brilliance iCT SP 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-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