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.

42651–42675 of 50511

  • HighFDA (Devices)·Z-0028-2014·2013-10-30

    Becton Dickinson Recalls BBL MGIT Mycobacteria Tubes Due to Barcode Error

    Becton Dickinson is recalling 187,000 BBL MGIT Mycobacteria Growth Indicator Tubes because incorrect barcodes may cause false negative test results.

    Product
    BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0007-2014·2013-10-30

    Vinco's OsteoSheath 4 Calcium Supplement Recalled for Salmonella Risk

    Vinco Inc. is recalling certain lots of OsteoSheath 4 calcium supplements because the soy ingredient used was potentially contaminated with Salmonella.

    Product
    Vinco's OsteoSheath 4 Enhanced Bone Support, Calcium Supplement, 120 Tablets, distributed by Vinco, Inc., Evans City, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0047-2014·2013-10-30

    Abbott Recalls STAR Excimer Laser Systems Due to Power Component Failure

    Abbott Medical Optics is recalling STAR Excimer Laser Systems because a power component failure can cause the lamp and illumination system to malfunction.

    Product
    STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kit Recall for Hex Wrench Defect

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because a hex wrench may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0076-2014·2013-10-30

    Dannon Oikos Blueberry Yogurt Recalled for Incorrect Blackberry Labeling

    Dannon is recalling Oikos Blueberry Greek Yogurt because the cups are incorrectly labeled as blackberry flavor, failing to declare the allergen carmine.

    Product
    DANNON OIKOS Fruit on the Bottom GREEK NONFAT YOGURT BLUEBERRY 0% FAT
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·14008·2013-10-30

    Southern Telecom Recalls A/C Adaptors for Polaroid Internet Tablets

    Southern Telecom is recalling A/C adaptors for Polaroid PMID 709 Internet Tablets due to a fire hazard. The adaptors can overheat, posing a risk of fire.

    Product
    A/C Adaptor (charger) included with Polaroid PMID 709 Internet Tablets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0051-2014·2013-10-30

    Synergetics 25 Gauge Soft Tip Cannula Recall Due to Gauge Mislabeling

    Synergetics Inc is recalling 25 gauge Soft Tip Cannulas because some units are co-mingled with 23 gauge cannulas but labeled as 25 gauge.

    Product
    Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0045-2014·2013-10-30

    Merit Medical Recalls Performa Angiographic Catheters Due to Tip Shape Variation

    Merit Medical Systems is recalling 200 units of Performa Angiographic Catheters because four lots contain a catheter with a slight variation in tip shape.

    Product
    Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0034-2014·2013-10-30

    GE Healthcare Recalls Centricity Cardio Imaging 5.0 Software

    GE Healthcare is recalling Centricity Cardio Imaging 5.0 software due to a potential image labeling error in the Image Viewer that may affect diagnostic interpretation.

    Product
    Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V532000·2013-10-29

    Prevost Recalls 81 Coaches Due to Accelerator Pedal Spring Defect

    Prevost is recalling 81 model year 2008-2010 coaches because broken accelerator pedal springs may prevent the pedal from returning to idle, increasing crash risk.

    Product
    PREVOST — PREVOST XLII-45 ENTERTAINER, H3 VIP, X3-45, H3-41
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14007·2013-10-29

    BreathableBaby Recalls Infant Wearable Blankets Due to Choking Hazard

    BreathableBaby is recalling specific infant wearable blankets because zipper parts can detach and pose a choking risk. No injuries have been reported.

    Product
    BreathableSack wearable blanket for infants
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14006·2013-10-29

    Target Recalls Circo Children's Sitting Stools Due to Fall Hazard

    Target is recalling about 69,000 Circo-brand Chloe and Conner sitting stools because the stabilizing bar can crack, causing the stool to collapse and posing a fall hazard to children.

    Product
    Circo-brand Chloe and Conner Sitting Stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V540000·2013-10-28

    Forest River Recalls Travel Trailers with Incorrect Tire Pressure Labels

    Forest River is recalling 2008-2011 travel trailers because incorrect tire inflation pressures on the certification label may lead to overinflation and sudden tire failure.

    Product
    ROCKWOOD — ROCKWOOD, FLAGSTAFF, CHEROKEE TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V526000·2013-10-25

    BMW Recalls 2012 K 1600 GT Motorcycles for Throttle Software Issue

    BMW is recalling 2,475 model year 2012 K 1600 GT and GTL motorcycles because a software error may cause the engine to stall, increasing crash risk.

    Product
    BMW — BMW K 1600 GT, K 1600 GTL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14005·2013-10-24

    Emerson Recalls Tommy Bahama Outdoor Ceiling Fans Due to Injury Risk

    Emerson Air Comfort Products is recalling specific Tommy Bahama outdoor ceiling fans because brackets can break, causing blades to fall and injure bystanders.

    Product
    Tommy Bahama® Outdoor Ceiling Fans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0005-2014·2013-10-23

    Dutch Valley Mixed Nuts Recalled for Undeclared Pecans

    Dutch Valley Food Development Inc. is recalling Roasted Salted Mixed Nuts with Peanuts due to undeclared pecans in the ingredient statement.

    Product
    Roasted Salted Mixed Nuts w/ Peanuts, net wt. 12 oz., packed in a clear plastic bag. Ingredients: blanched peanuts, unblanched peanuts, unblanched almonds, unblanched Brazil nuts, unblanched filberts, cashews cooked in canola oil, salt. Allergen info: peanut and tree…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2014·2013-10-23

    GE PET Discovery 610 and 710 Recalled for Image Series UID Conflict

    GE Healthcare is recalling PET scanners because a software issue may cause different image series to share the same ID, potentially leading to incorrect image display.

    Product
    GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2014·2013-10-23

    Boston Scientific COGNIS CRT-D Recall for Premature Battery Depletion

    Boston Scientific is recalling COGNIS CRT-D devices because a capacitor defect may cause premature battery depletion.

    Product
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0026-2014·2013-10-23

    Boston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion Risk

    Boston Scientific is recalling TELIGEN implantable cardiac defibrillators because a capacitor defect may cause premature battery depletion.

    Product
    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0011-2014·2013-10-23

    Siemens Recalls ADVIA Hematology Systems Due to Sample Labeling Error Risk

    Siemens is recalling ADVIA 2120/2120i hematology systems connected to an ADVIA Autoslide because a rack jam error could cause the next slide to be labeled with the wrong sample identification information.

    Product
    ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-66272-001·2013-10-23

    Infant ibuprofen drops are recalled nationwide for process-related particulates

    McNeil Consumer Healthcare is recalling 197,532 bottles of Concentrated Motrin Infants' Drops because process-related particulates were observed. The affected bottles were distributed nationwide.

    Product
    Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor 1/2 fl oz bottles, 50 mg per 1.25ml, Distributed by McNeil Consumer Healthcare, Fort Washington, PA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0014-2014·2013-10-23

    Synthes Midfoot Fusion Bolt Recall for Technique Guide Clarification

    Synthes USA is recalling 62 Midfoot Fusion Bolts to update the technique guide, emphasizing supplemental fixation to reduce the risk of bolt back-out or migration.

    Product
    Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
    Category
    Medical Device
    Distribution
    Distributed nationwide