The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

39801–39825 of 50506

  • HighFDA (Devices)·Z-0807-2015·2014-12-24

    Siemens Biograph mCT Flow Edge-4R Recalled for Display Freeze Risk

    Siemens Medical Solutions USA Inc. is recalling four Biograph mCT Flow Edge-4R scanners due to a potential system display freeze during CT interventional procedures.

    Product
    Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0825-2015·2014-12-24

    DePuy Ceramic Femoral Head Recalled for Fit Issues in Hip Surgery

    DePuy Orthopaedics is recalling 19 units of BIOLOX delta TS Ceramic Femoral Heads due to reports that the device did not fit as expected during hip surgery.

    Product
    Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0815-2015·2014-12-24

    Philips QLAB Software Recall for Incorrect Ejection Fraction Calculations

    Philips Ultrasound is recalling QLAB software versions 10.0, 10.1, and 10.1.1 because automated quantification features may report inaccurate cardiac measurements, potentially leading to misdiagnosis.

    Product
    Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field…
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0236-2015·2014-12-24

    Philips Brilliance iCT Computed Tomography System Software Defect Recall

    Philips Medical Systems is recalling 16 Brilliance iCT Computed Tomography X-Ray Systems due to a software defect that may prevent scans from terminating at the intended location.

    Product
    Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0728-2015·2014-12-24

    Kozy Shack Chocolate Pudding Recalled for Undeclared Milk

    Kozy Shack is recalling Simply Well Chocolate Pudding due to undeclared milk and incomplete labeling. The recall affects 1,774 cartons distributed across 20 states.

    Product
    KOZY SHACK SIMPLY WELL CHOCOLATE, NET WT 4 OZ. Product packed in brown carton box, 48 individual units x 4 OZ. Keep Refrigerated. Made in USA
    Category
    Food
    Distribution
    20 states
  • HighFDA (Drugs)·D-0301-2015·2014-12-24

    Baxter Recalls Clinimix E IV Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 7,220 bags of Clinimix E IV solution because leaks were observed, raising concerns about sterility.

    Product
    CLINIMIX E — CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0729-2015·2014-12-24

    Whalen's Seafood Sauce Recalled for Undeclared Anchovies

    Whalen's Seafood & Burger Sauce is being recalled because it contains undeclared anchovies and has incomplete ingredient labeling.

    Product
    WHALEN'S SEAFOOD & BURGER SAUCE "HOT", NET WT. 8 OZ. (226 g) -- Whalen's Horseradish Products, LLC, PO Box 4700, Saratoga Springs, New York 12866
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0725-2015·2014-12-24

    Wegmans Recalls Fresh Sliced Peaches, Plums, Nectarines, and Desserts

    Wegmans is voluntarily recalling fresh sliced peaches, plums, nectarines, peach salsa, and in-store baked desserts due to potential Listeria monocytogenes contamination.

    Product
    Sliced Yellow Peaches, made fresh in-store and packaged. Sold pre-packaged in random weights.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0805-2015·2014-12-24

    AMS Monarc Subfascial Hammock Kits Recalled for Packaging Integrity Concerns

    American Medical Systems is recalling Monarc + and Monarc C Subfascial Hammock kits because routine testing showed the sterile packaging might fail during extreme shipping.

    Product
    AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0800-2015·2014-12-24

    Carestream DRX-Revolution Mobile X-Ray System Recalled for Broken Bolts

    Carestream Health is recalling 629 DRX-Revolution Mobile X-Ray Systems because bolts securing the x-ray tube assembly may break, posing a risk of equipment failure.

    Product
    DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0724-2015·2014-12-24

    Wegmans Recalls Fresh Stone Fruits and Desserts for Listeria Risk

    Wegmans is voluntarily recalling fresh plums, nectarines, peaches, peach salsa, and in-store baked desserts that may contain these fruits due to potential Listeria monocytogenes contamination.

    Product
    Vanilla Trifle, 8 oz., UPC 7789080600
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0803-2015·2014-12-24

    Stryker Spine Recalls Specialty Audible Torque Wrench Due to Fracture

    Stryker Spine is recalling 15 units of the Specialty Audible Torque Wrench (Lot 4279) after a customer reported the device fractured during surgery.

    Product
    Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0508-2015·2014-12-24

    Philips MobileDiagnost wDR Recalled for Unintended Radiation Exposure Risk

    Philips Medical Systems is recalling MobileDiagnost wDR units due to a potential for unintended radiation exposure during start-up.

    Product
    Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0718-2015·2014-12-24

    Wegmans Recalls Fresh Stone Fruits and Baked Desserts for Listeria Risk

    Wegmans is voluntarily recalling fresh plums, nectarines, peaches, peach salsa, and in-store baked desserts that may contain these fruits due to potential Listeria monocytogenes contamination.

    Product
    Small Fruit-Topped Cheese Cake, 18 oz., UPC 7789026441 Large Fruit-Topped Cheese Cake, 54 oz., UPC 7789026438 Fruit-Topped Cream Cheese Pie, 40 oz., UPC 7789018953
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0801-2015·2014-12-24

    Siemens Recalls Turbo Troponin I Diagnostic Kits for Potential Diagnostic Errors

    Siemens Healthcare Diagnostics is recalling 3,622 Turbo Troponin I kits used to diagnose heart attacks due to a Class II safety concern.

    Product
    Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0830-2015·2014-12-24

    Mako Surgical Recalls RESTORIS PST Acetabular Offset Shell Impactors

    Mako Surgical Corporation is recalling 404 RESTORIS PST Acetabular Offset Shell Impactors because they may be damaged during surgery.

    Product
    RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0777-2015·2014-12-24

    Stryker Laparoscopic Scissors Recalled for Sterilization Parameter Errors

    Stryker Endoscopy is recalling 180,573 laparoscopic hook scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, HOOK SCISSORS, 29CM, P/N 0250282049 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0810-2015·2014-12-24

    Siemens Biograph mCT Scanners Recalled for Potential Display Freeze

    Siemens Medical Solutions is recalling eight Biograph mCT S(64)-4R scanners due to a risk of system display freeze during CT interventional procedures.

    Product
    Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0809-2015·2014-12-24

    Siemens Biograph mCT X-4R Recalled for Potential Display Freeze During Procedures

    Siemens Medical Solutions is recalling eight Biograph mCT X-4R scanners due to a possibility of system display freeze during CT interventional procedures.

    Product
    Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0721-2015·2014-12-24

    Wegmans Recalls Fresh Fruit and Desserts for Listeria Risk

    Wegmans is voluntarily recalling fresh plums, nectarines, peaches, peach salsa, and specific in-store baked tarts due to potential Listeria monocytogenes contamination.

    Product
    Peach Melba Tart, 26 oz., UPC 7789098553; Rectangular Fruit Tart, 37 oz., UPC 20823800000; Mixed Fruit Tart, 30 oz., UPC 20819500000; Square Fruit Tart, 48 oz., UPC 20823700000; Frangipane Tart, 30 oz., UPC 7789091064
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0723-2015·2014-12-24

    Wegmans Recalls Fresh Stone Fruits and Desserts for Listeria Risk

    Wegmans is voluntarily recalling fresh plums, nectarines, peaches, peach salsa, and in-store baked desserts that may contain these fruits due to potential Listeria monocytogenes contamination.

    Product
    Lg. Fruit Crostata, 21 oz., UPC 20829300000; Sm. Fruit Crostata, 7 oz., UPC 20829900000; Lg. Nectarine Crostata, 21 oz., UPC 20823100000; Sm. Nectarine Crostata, 6 oz., UPC 20832600000
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0811-2015·2014-12-24

    Siemens Biograph mCT S(40)-4R Recalled for Display Freeze Risk

    Siemens Medical Solutions is recalling eight Biograph mCT S(40)-4R scanners due to a potential system display freeze during CT interventional procedures.

    Product
    Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0759-2015·2014-12-24

    Stryker Laparoscopic Scissors Recalled for Sterilization Instructions Error

    Stryker Endoscopy is recalling 180,573 units of 3mm Peritoneal Scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, PERITONEAL SCISSORS, 20CM, P/N 0250282001 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2015·2014-12-24

    GE Healthcare Recalls Discovery IGS 740 Imaging Systems Due to Loss of Function

    GE Healthcare is recalling Discovery IGS 740 systems because they may lose real-time imaging or motion capabilities due to electromagnetic sensitivity.

    Product
    Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0821-2015·2014-12-24

    Mitsubishi VERO Linear Accelerator Software Recall for Image Display Error

    Mitsubishi Heavy Industries is recalling four VERO Linear Accelerator systems in the US due to a software anomaly that may display incorrect image angles for patient positioning.

    Product
    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
    Category
    Medical Device
    Distribution
    4 states