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.

35901–35925 of 50504

  • HighFDA (Devices)·Z-1559-2016·2016-05-04

    Becton Dickinson Recalls Listeria-Contaminated Trypticase Soy Agar Plates

    Becton Dickinson is recalling Trypticase Soy Agar and MacConkey II Agar plates contaminated with Listeria monocytogenes. The non-sterile media are used for growing and detecting bacteria.

    Product
    Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: Trypticase Soy Agar with 5% Sheep Blood is used for the growth of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1258-2016·2016-05-04

    Shaw's Eggplant and Cheese Wrap Recalled for Potential Glass Fragments

    Flying Food Group LLC is recalling Shaw's Brand Market Fresh Eggplant & Cheese Wraps due to a potential for glass fragments from a supplier raw material recall.

    Product
    Shaw's Brand Market Fresh Eggplant & Cheese Wrap, 10.0 oz packaged in plastic inside a paper open box
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1553-2016·2016-05-04

    Horiba Recalls ABX Pentra 400 Analyzers Due to Malfunctions

    Horiba Instruments is recalling ABX Pentra 400 and Pentra C400 analyzers because they malfunction when specific alarms appear on the system.

    Product
    ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1255-2016·2016-05-04

    Dietz & Watson Italian Sub Recalled for Potential Glass Fragments

    Flying Food Group LLC is recalling Dietz & Watson Italian Sub 7.3 oz bags due to potential glass fragments from a supplier's raw material recall.

    Product
    Dietz & Watson Brand Italian Sub 7.3 oz bag
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1247-2016·2016-05-04

    Duncan Hines Swiss Chocolate Cake Mix Recalled for Undeclared Milk

    Pinnacle Foods is recalling Duncan Hines Swiss Chocolate Cake Mix because a natural flavoring containing milk was used, but the product was labeled as non-milk.

    Product
    Duncan Hines Signature Swiss Chocolate Cake Mix, 16.5 oz. cartons, Distributed by: Pinnacle Foods, Cherry Hill, New Jersey USA, UPC 6 44209 41120 7
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1561-2016·2016-05-04

    Elekta Radionuclide Radiation Therapy System Recalled for Frame Adapter Latch Defect

    Elekta is recalling 217 Radionuclide Radiation Therapy Systems because frame adapter latches can lock without proper pin insertion, potentially compromising treatment accuracy.

    Product
    Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1254-2016·2016-05-04

    Dunkin Donuts Italian Sub Recalled for Potential Glass Fragments

    Flying Food Group LLC is recalling Dunkin Donuts Brand Italian Subs due to a potential for glass fragments from a supplier raw material recall.

    Product
    Dunkin Donuts Brand Italian Sub, Net Wt 7.7 oz packaged in Bag, Clear View
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1563-2016·2016-05-04

    3M Steri-Vac Gas Sterilizer Valves Recalled for Labeling Error

    3M is recalling 74 Steri-Vac Gas Sterilizer valves due to a labeling error that could cause incorrect installation and potential valve failure.

    Product
    3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1558-2016·2016-05-04

    Siemens SOMATOM Force CT Systems Recalled for Image Artifacts

    Siemens is recalling 37 SOMATOM Force CT systems because a software error in the Neonate Head protocol may cause image artifacts, potentially leading to misdiagnosis.

    Product
    SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1259-2016·2016-05-04

    Shaw's Italian Sub Recalled for Potential Glass Fragments

    Flying Food Group LLC is recalling Shaw's Brand Market Fresh Italian Subs due to a potential risk of glass fragments from raw materials.

    Product
    Shaw's Brand Market Fresh Shaw Market Fresh Italian Sub, 8.3 oz. wrapped in plastic in open paper box container
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1131-2016·2016-05-04

    NOW Foods Recalls Gingko Biloba Supplements Due to Undeclared Soy

    NOW Foods is recalling Gingko Biloba 60mg capsules because they contain undeclared soy lecithin. Consumers should stop using the product and return it to the place of purchase.

    Product
    Gingko Biloba 60mg packaged in a white and orange bottle containing 120 capsules. The bottle has a blue cap and white lettering.
    Category
    Food
    Distribution
    49 states
  • HighFDA (Food)·F-1133-2016·2016-05-04

    NOW Foods Recalls Cranberry Extract for Undeclared Soy Lecithin

    NOW Foods is recalling 3 bottles of cranberry extract capsules due to undeclared soy lecithin. The product was distributed to 499 consignees in the US and one in Japan.

    Product
    Cranberry extract packaged in a white and orange bottle containing 90 capsules. The bottle has a blue cap and white lettering.
    Category
    Food
    Distribution
    49 states
  • HighNHTSA·16V268000·2016-05-04

    Volvo Recalls 2016 XC90 Vehicles Due to Sunroof Switch Defect

    Volvo is recalling 2016 XC90 vehicles because the sunroof switch may be unintentionally pressed, causing the panel to close and increasing the risk of occupant injury.

    Product
    VOLVO — VOLVO XC90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2016·2016-05-04

    Hologic Recalls CF InPlex ASR Cards Due to False Positive Results

    Hologic is recalling CF InPlex ASR Cards because they may produce false positive results or leak, potentially leading to unnecessary invasive testing during pregnancy.

    Product
    CF InPlex ASR Card; Catalog Number: 95-0501.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Food)·F-1029-2016·2016-05-04

    Starbucks Cheese and Fruit Bistro Box Recalled for Undeclared Cashews

    Gretchen's Shoebox Express is recalling Starbucks Cheese & Fruit Bistro Boxes because they may contain undeclared cashews.

    Product
    Cheese & Fruit Bistro Box (Item #11015085), Starbucks brand. Product is packaged in plastic clamshell, net wt. 5.3 oz. The UPC is 7 62111 88146 5.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1129-2016·2016-05-04

    NOW Foods Andrographis Extract Recalled for Undeclared Soy Lecithin

    NOW Foods is recalling Andrographis extract 400 mg capsules due to undeclared soy lecithin. The product was distributed to 499 consignees in the US and one in Japan.

    Product
    Andrographis extract 400 mg packaged in a white and orange bottle containing 90 capsules. The bottle has a blue cap and white lettering.
    Category
    Food
    Distribution
    49 states
  • HighFDA (Devices)·Z-1578-2016·2016-05-04

    Roche IT3800 Hand-Held Barcode Scanner Recalled for Mis-Identification

    Roche Molecular Systems is recalling 6,939 IT3800 hand-held barcode scanners because they mis-identified sample barcodes when used with the COBAS AmpliPrep instrument.

    Product
    Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2016·2016-05-04

    Philips NeuViz 16 CT Scanner Recall for Patient Data Error

    Philips and Neusoft are recalling 37 NeuViz 16 CT scanners due to a software defect that may allow previous patient images to be pasted into the current patient's record.

    Product
    NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1585-2016·2016-05-04

    Shimadzu X-Ray Diagnostic Table Recalled for Unintentional Reverse Tilting

    Shimadzu Medical Systems is recalling 185 X-Ray Diagnostic Tables (Model YSF-300) due to reports of unintentional movement to reverse tilting.

    Product
    X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1568-2016·2016-05-04

    Intuitive Surgical Recalls da Vinci Xi Stapler Instruments Due to Motion Risk

    Intuitive Surgical is recalling 43 EndoWrist Stapler instruments for the da Vinci Xi system due to a risk of unexpected jaw motion during use.

    Product
    EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1132-2016·2016-05-04

    NOW Foods Recalls Goldenseal Root Supplements Due to Undeclared Soy Lecithin

    NOW Foods is recalling Goldenseal Root 500 mg capsules because they contain undeclared soy lecithin, a common allergen.

    Product
    Goldenseal Root 500 mg packaged in a white and orange bottle containing 100 capsules. The bottle has a blue cap and white lettering.
    Category
    Food
    Distribution
    49 states
  • HighFDA (Food)·F-1256-2016·2016-05-04

    Shaw's Turkey Sandwiches Recalled for Potential Glass Fragments

    Flying Food Group LLC is recalling Shaw's Brand Market Fresh Turkey & Roasted Red Peppers on Wheat sandwiches due to potential glass fragments from raw materials.

    Product
    Shaw's Brand Market Fresh Turkey & Roasted Red Peppers on Wheat, 5.4 oz. packaged in a wedge container
    Category
    Food
    Distribution
    5 states
  • HighCPSC·16155·2016-05-03

    Cascade Designs Recalls Avalanche Rescue Probes Due to Suffocation Risk

    Cascade Designs is recalling Striker 320 and 240 avalanche rescue probes because a lock button failure may prevent the probe from extending, posing a suffocation hazard.

    Product
    Avalanche rescue probes
    Category
    Consumer Product
    Distribution
    Distributed nationwide