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.

39776–39800 of 50506

  • HighFDA (Devices)·Z-0853-2015·2014-12-31

    Zimmer Recalls Persona Cemented Tibial Broach Inserter/Extractor Handles

    Zimmer, Inc. is recalling 83 units of Persona Cemented Tibial Broach Inserter/Extractor Handles because the magnet cover may disassociate and be lost during surgery.

    Product
    Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0873-2015·2014-12-31

    Radiometer HemoCue Glucose 201 Microcuvettes Recalled for Discoloration and Inaccurate Results

    Radiometer America Inc. is recalling HemoCue Glucose 201 Microcuvettes because they show discoloration and provide results outside specification near the end of their shelf life.

    Product
    HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2015·2014-12-31

    Bausch & Lomb Stellaris PC Laser Recall for Software Anomaly

    Bausch & Lomb is recalling 106 Stellaris PC laser systems because a software anomaly may cause the device to automatically transition from Standby to Ready to Fire during surgery.

    Product
    Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-0832-2015·2014-12-31

    Instrumentation Laboratory Recalls HemosIL PT-Fibrinogen HS PLUS Reagent

    Instrumentation Laboratory is recalling HemosIL PT-Fibrinogen HS PLUS reagent kits because some vials exhibit discoloration that causes prolonged prothrombin clotting times.

    Product
    HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0864-2015·2014-12-31

    Bausch & Lomb Stellaris PC Vision Enhancement System Recalled for Software Anomaly

    Bausch & Lomb is recalling two Stellaris PC Vision Enhancement Systems because a software anomaly may cause the device to automatically transition from Standby to Ready to Fire during surgery.

    Product
    Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and…
    Category
    Medical Device
    Distribution
    21 states
  • HighNHTSA·14V828000·2014-12-30

    Toyota and Scion Recall for Improperly Installed Accessories

    Southeast Toyota Distributors is recalling 2014-2015 Toyota and Scion vehicles because accessories like running boards may have been installed with improperly tightened fasteners.

    Product
    SCION — SCION, TOYOTA XB, RAV4, LAND CRUISER, FJ CRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V824000·2014-12-29

    Porsche Recalls 2015 Cayenne Vehicles for Suspension Alignment Defect

    Porsche is recalling specific 2015 Cayenne Diesel and Cayenne S vehicles because incorrect suspension alignment may reduce vehicle handling and increase crash risk.

    Product
    PORSCHE — PORSCHE CAYENNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V825000·2014-12-29

    Dodgen Recalls Mobility RVs Due to Wheelchair Lift Platform Cracking Risk

    Dodgen is recalling 2006-2014 Mobile Tech. Mobility RVs equipped with specific Ricon wheelchair lifts because the platform side plate may crack, posing an injury risk.

    Product
    DODGEN — DODGEN MOBILE TECH. MOBILITY RV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0720-2015·2014-12-24

    Wegmans Recalls Fresh Stone Fruits and Desserts for Listeria Risk

    Wegmans is voluntarily recalling fresh plums, nectarines, peaches, and related desserts due to potential Listeria monocytogenes contamination.

    Product
    Peach Melba Whipped Cream Pie, 34 oz., UPC 7789033104
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0828-2015·2014-12-24

    Mako Surgical Recalls RESTORIS PST Straight Shell Impactors

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

    Product
    RESTORIS PST Straight Shell Inserter 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-0816-2015·2014-12-24

    Philips EPIQ 5 Ultrasound System Recalled for Incorrect Ejection Fraction Calculations

    Philips is recalling EPIQ 5 Ultrasound Systems because specific software plug-ins may calculate incorrect ejection fractions, potentially leading to misdiagnosis or delayed therapy.

    Product
    EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Food)·F-0726-2015·2014-12-24

    Wegmans Recalls Sliced Nectarines and Peaches for Listeria Risk

    Wegmans is recalling sliced nectarines, plums, peaches, and related products due to potential Listeria monocytogenes contamination.

    Product
    Sliced Yellow Nectarines, made fresh in-store and packaged. Sold pre-packaged in random weights.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0818-2015·2014-12-24

    Philips Q-Station Software Recalled for Potential Incorrect Cardiac Measurements

    Philips is recalling Q-Station 3.0 software because automated cardiac measurements may be inaccurate, potentially leading to misdiagnosis or incorrect therapy.

    Product
    Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0817-2015·2014-12-24

    Philips EPIQ 7 Ultrasound Systems Recalled for Incorrect Ejection Fraction Calculations

    Philips is recalling EPIQ 7 ultrasound systems because specific software plug-ins may calculate incorrect ejection fractions, potentially leading to misdiagnosis or incorrect therapy.

    Product
    EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPIC 7C, EPIQ 7W; Catalog Number: 795200 / 795201 and Part Number: 989605386721. Diagnostic Ultrasound Imaging.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0808-2015·2014-12-24

    Siemens Biograph mCT Flow 40-4R Recalled for Display Freeze Risk

    Siemens Medical Solutions is recalling one Biograph mCT Flow 40-4R scanner due to a potential display freeze during CT interventional procedures.

    Product
    Biograph mCT Flow 40-4R, System Material Number 10529159. 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-0451-2015·2014-12-24

    GE Healthcare Recalls Innova IGS 540 Imaging Systems Due to Motion Loss

    GE Healthcare is recalling 10 Innova IGS 540 systems because they may lose real-time imaging or gantry motion due to electromagnetic sensitivity.

    Product
    Innova IGS 540 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 (Food)·F-0722-2015·2014-12-24

    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
    Lg. Fruit Strip "Puff Pastry", 11 oz., UPC 20829200000; Sm. Fruit Strip "Puff Pastry", 3 oz., UPC 20829100000
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0754-2015·2014-12-24

    Stryker Johann Forceps Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling Johann Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM X 45CM INSERT, JOHANN FORCEPS, P/N 0250080764 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-0526-2015·2014-12-24

    Varian On-Board Imager X-ray Generators Recalled for Missing Ground Wire

    Varian Medical Systems is recalling 32 On-Board Imager systems because the X-ray generators are missing a required ground wire.

    Product
    Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land¿¿ marks.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0453-2015·2014-12-24

    GE Healthcare Recalls Innova 4100IQ Fluoroscopic Imaging Systems

    GE Healthcare is recalling six Innova 4100IQ fluoroscopic systems due to a defect that may cause loss of real-time imaging or gantry motion.

    Product
    Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0829-2015·2014-12-24

    Mako Surgical Recalls RESTORIS PST Acetabular Straight Shell Impactors

    Mako Surgical Corporation is recalling 404 RESTORIS PST Acetabular Straight Shell Impactors due to the potential for intraoperative damage.

    Product
    RESTORIS PST Acetabular Straight 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 (Food)·F-0743-2015·2014-12-24

    HyVee Mozzarella Sticks Recalled for Undeclared Soy and Dyes

    Great American Appetizers is recalling HyVee Mozzarella Sticks because the product contains soy flour and dyes not listed on the label.

    Product
    Mozzarella cheese sticks are breaded Mozzarella Stick designed to be cooked in either the oven or a fryer. The package contains a clear inner plastic sealed bag with the food product, inside a cardboard larger carton. The net weight is 8 oz., and there are 12 units per case.…
    Category
    Food
    Distribution
    1 state