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.

34501–34525 of 50502

  • HighFDA (Devices)·Z-0043-2017·2016-10-12

    Trumpf Medical Systems Recalls TruSystem Operating Tables Due to Unexpected Descent

    Trumpf Medical Systems is recalling 84 TruSystem 7000 U operating tables because they may unexpectedly descend approximately 20 centimeters.

    Product
    Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0042-2017·2016-10-12

    Trumpf Medical Systems Recalls Floor Mounting Columns for Unexpected Descent

    Trumpf Medical Systems is recalling 84 Floor Mounting Columns because they unexpectedly descended approximately 20 centimeters, posing a risk to patient safety during surgery.

    Product
    Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-2606-2016·2016-10-12

    Apple Pecan Cake Recalled for Missing Pecan Allergen Labeling

    Creative Occasions, Inc. is recalling Patti's good life Premium Apple Pecan Cake because the ingredient statement failed to declare pecans.

    Product
    Patti's good life PREMIUM APPLE PECAN CAKE, NET WT 20 OZ (1 LB 4 OZ) 567g, UPC 89028800290
    Category
    Food
    Distribution
    10 states
  • HighNHTSA·16V732000·2016-10-12

    Coachmen Galleria Recalled for Incorrect Cargo Capacity Placard

    Forest River is recalling 2016-2017 Coachmen Galleria recreational vehicles because the cargo capacity placard is inaccurate, which may lead to overloading.

    Product
    COACHMEN — COACHMEN GALLERIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V730000·2016-10-12

    ShowHauler Garage Coach Lift Gate Chain Recall

    ShowHauler is recalling 2014-2015 Garage Coaches because lift gate roller chains may fail, causing the platform to drop and increasing injury risk.

    Product
    SHOWHAULER — SHOWHAULER GARAGE COACH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2307-2016·2016-10-12

    Four Seasons Pecan Tarts Recalled for Undeclared Milk

    Charlie's Specialties, Inc. is recalling Four Seasons Pecan Tarts because they contain undeclared milk. The product was distributed in Ohio.

    Product
    Four Seasons Pecan Tarts; 202 4T0867 ; Sel By: 09/10/2016, 09/15/15, 10/13/16,10/28/16; and 12/10/15, 12/15/15, 01/13/16, 01/28/16 (lot numbers). 180 Pieces; Weight 8#; Packed exclusively for International Market Brands, Cleveland, Ohio 44146.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0013-2017·2016-10-12

    Siemens Recalls Multix Fusion X-Ray Systems Due to Table Tilt Risk

    Siemens is recalling 37 Multix Fusion X-ray systems because an internal table part may detach, causing the table to tilt and potentially injure patients.

    Product
    Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0005-2017·2016-10-12

    Progressive Gourmet Recalls Sausage, Egg, and Cheese Muffins for Listeria Risk

    Progressive Gourmet Inc. is recalling frozen Sausage, Egg, and Cheese on English Muffin products manufactured for Starbucks due to Listeria monocytogenes contamination found on food contact surfaces.

    Product
    Sausage, Egg, and Cheese on English Muffin, Fully Cooked, Keep Frozen, Perishable-30/case Manufactured Exclusively for Starbucks Coffee Company, Seattle, WA 98134 Product Date: 10/FEB/2016 SKU: 11041857 Not Labeled for Retail Sale
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2639-2016·2016-10-12

    Martinelli Sparkling Cider Gift Baskets Recalled for Potential Glass Chips

    DesignPac Gifts is recalling Elegant Sophistication gift baskets containing Martinelli Sparkling Cider due to a risk of glass chips entering the beverage.

    Product
    Elegant sophistication gift basket containing apple cidar in glass bottles. The label on the back of the gift basket is white with black lettering.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0038-2017·2016-10-12

    RayStation Radiation Therapy Planning Software Recalled for Dose Calculation Errors

    RaySearch is recalling RayStation software versions 2.5 through 5.0 due to dose calculation errors when using specific region of interest settings.

    Product
    RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2905-2016·2016-10-12

    Integra Straight Ventricular Catheter Recalled for Incomplete Packaging Seal

    Integra LifeSciences Corp. is recalling 10 units of Straight Ventricular Catheters due to an incomplete packaging seal discovered during final inspection.

    Product
    Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Catheter for use with hydrocephalus valves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2909-2016·2016-10-12

    Integra Ventricular Catheter Accessory Kit Recalled for Incomplete Packaging Seal

    Integra LifeSciences Corp. is recalling 14 units of the Ventricular Catheter Accessory Kit due to an incomplete sterile packaging seal discovered during final inspection.

    Product
    Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0039-2017·2016-10-12

    Siemens Dimension Vista Calcium Reagent Cartridge Recall for Erroneous Results

    Siemens Healthcare Diagnostics is recalling Dimension Vista Calcium reagent cartridges that may produce inaccurate test results.

    Product
    Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0014-2017·2016-10-12

    Siemens Recalls Multix Fusion VA10 Radiographic Systems Due to Table Defect

    Siemens is recalling 37 Multix Fusion VA10 radiographic systems because a table part may detach, causing the table to tilt and potentially injure patients.

    Product
    Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including:skull, chest, abdomen and extremities and may be used on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0008-2017·2016-10-12

    Microgenics Recalls QMS Everolimus Assay Due to Reagent Stability Issue

    Microgenics Corporation is recalling the Thermo Scientific QMS Everolimus Assay because a reagent stability issue causes inaccurate test results for transplant patients.

    Product
    Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2017·2016-10-12

    Zimmer Biomet Recalls Vanguard 360 Knee Prostheses Due to Bolt Defect

    Zimmer Biomet is recalling 454 Vanguard 360 Revision Knee System prostheses because a manufacturing defect in the tibial augment bolts may prevent them from being fully tightened during surgery.

    Product
    Vanguard 360 Revision Knee System Knee prostheses
    Category
    Medical Device
    Distribution
    9 states
  • HighCPSC·17010·2016-10-12

    Mamas & Papas Recalls Armadillo Strollers Due to Fall Hazard

    Mamas & Papas is recalling Armadillo Flip and Flip XT strollers because a loose latch can cause the seat to tip back, posing a fall hazard to infants.

    Product
    Mamas & Papas Armadillo Flip Strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0045-2017·2016-10-12

    LDR Spine Recalls ROI-A Anterior Delivery Device Due to Binding

    LDR Spine USA is recalling 24 units of the ROI-A Anterior Delivery Device because the T-handle rotation has experienced binding. No patient injuries have been reported.

    Product
    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
    Category
    Medical Device
    Distribution
    7 states
  • HighNHTSA·16V728000·2016-10-12

    Forest River Recalls 2017 Trailers Due to Air Conditioner Fire Risk

    Forest River is recalling 2017 Flagstaff and Rockwood trailers because excess slack in air conditioner wiring may contact heating elements, increasing fire risk.

    Product
    FOREST RIVER — FOREST RIVER ROCKWOOD, FLAGSTAFF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2017·2016-10-12

    Panoramic PC-1000 X-ray Systems Recalled for Safety Nut Defect

    Panoramic Rental Corp. is voluntarily correcting PC-1000 X-ray systems because a safety nut may be ineffective, posing a risk of blunt force trauma to the head, neck, or shoulders.

    Product
    Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V727000·2016-10-12

    Keystone Recalls 2017 Dutchmen Coleman Trailers for Wiring Fire Risk

    Keystone RV is recalling 84 model year 2017 Dutchmen Coleman recreational trailers because loose or frayed wiring in the power center may increase the risk of a fire.

    Product
    DUTCHMEN — DUTCHMEN COLEMAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V724000·2016-10-11

    Nissan Recalls 2017 Versa Vehicles for Side Air Bag Defect

    Nissan is recalling 2017 Versa vehicles because a seam in the side curtain air bags may tear during deployment, increasing the risk of injury in a crash.

    Product
    NISSAN — NISSAN VERSA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V725000·2016-10-11

    Honda Recalls 2016 Civic Vehicles Due to Electric Parking Brake Defect

    Honda is recalling 2016 Civic vehicles because the electric parking brake may fail to engage immediately after the ignition is turned off, increasing the risk of the vehicle rolling away.

    Product
    HONDA — HONDA CIVIC
    Category
    Vehicle
    Distribution
    Distributed nationwide