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.

34426–34450 of 50502

  • HighFDA (Food)·F-0036-2017·2016-10-19

    Weis Markets Recalls Bakery Products Due to Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to potential small metal fragments in the sugar topping.

    Product
    Gourmet Raisin Bran Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0076-2017·2016-10-19

    Elekta Monaco RTP System Recalled for Incorrect Dose Calculation

    Elekta is recalling 365 Monaco RTP Systems because a software error can cause incorrect MU scaling when specific plan parameters are modified.

    Product
    Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose…
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-0037-2017·2016-10-19

    Weis Markets Recalls Pistachio Muffins Due to Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including pistachio muffins, due to potential metal fragments in the sugar topping.

    Product
    Gourmet Pistachio Flavored Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0086-2017·2016-10-19

    Pure Ghee Recalls Vrindavan Cow Ghee Due to Undeclared Milk Allergen

    Pure Ghee, Inc. is voluntarily recalling Vrindavan Cow Ghee because it contains an undeclared milk allergen. The product was distributed in New Jersey and New York.

    Product
    "VRINDAVAN" COW GHEE, Ingredients: 100% clarified butter
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0027-2017·2016-10-19

    Weis Markets Recalls 30 Bakery Products Due to Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins, cookies, and bread, due to potential metal fragments in the sugar topping.

    Product
    Peach Melba Loaf Bread (1 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0038-2017·2016-10-19

    Pharmedium Recalls Fentanyl Citrate Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 997 syringes of fentanyl citrate injection because stability data does not support the expiry date, posing a potential loss of potency.

    Product
    fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2017·2016-10-19

    Siemens Symbia T Series SPECT + CT Recall for Bearing Failure Risk

    Siemens Medical Solutions is recalling 1,109 Symbia T Series SPECT + CT systems because linear bearing cars may fail, allowing ball bearings to fall out.

    Product
    Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2017·2016-10-19

    Stryker Orthopaedics Recalls Universal Acetabular Cup Positioner/Impactor

    Stryker Howmedica Osteonics Corp. is recalling 3,768 units of the Universal Acetabular Cup Positioner/Impactor because the thread length may protrude past the dome of the acetabular trial or implant.

    Product
    Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0053-2017·2016-10-19

    Publix Raspberry Strip Danish Recalled for Metal Shavings

    Gold Standard Baking is recalling Publix Raspberry Strip Danishes due to the presence of small metal shavings.

    Product
    Publix Raspberry Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0031-2017·2016-10-19

    Weis Markets Recalls Bakery Products Due to Potential Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to the potential presence of small metal fragments in the sugar topping.

    Product
    Old Fashioned Shortcake (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0061-2017·2016-10-19

    Siemens Symbia S Camera Systems Recalled for Bearing Failure Risk

    Siemens Medical Solutions is recalling Symbia S camera systems because linear bearing cars may fail, allowing ball bearings to fall out.

    Product
    Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT component is intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0014-2017·2016-10-19

    Weis Markets Recalls 30 Bakery Products Due to Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to potential small metal fragments in the sugar topping.

    Product
    Gourmet Banana Nut Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0076-2017·2016-10-19

    R.W. Garcia Kale Crackers Recalled for Metal Fragments

    R.W. Garcia is recalling 49 cases of 3 Seed Kale Crackers due to the detection of metal fragments in raw material.

    Product
    RW Garcia, 3 Seed, Kale Crackers, Gluten Free, Net Wt. 180g, Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., Las Vegas, NV 89115 and Lincoln, NC 28092, Distributed by Clean Foods, Ltd, Legion House, 75 Lower Road, Kenley, Surrey, CR8 5NH.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0069-2017·2016-10-19

    Cardinal Health Recalls V. Mueller Spinal Distraction Screws Due to Corrosion

    Cardinal Health 200, LLC is recalling V. Mueller Neuro/Spine Shadow-Line Spinal Distraction Screws because corrosion was demonstrated on the screw surface.

    Product
    V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0085-2017·2016-10-19

    Trader Joe's Hummus Dip Recalled for Potential Sesame Allergen

    Tribe Mediterranean Foods is recalling Trader Joe's Freshly Made Original Hummus Dip (Tahini Free) because it may contain sesame, a major food allergen.

    Product
    Trader Joes Freshly Made Original Hummus Dip (Tahini Free), packaged in 16 oz. clear plastic cups SKU: 00299091
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0022-2017·2016-10-19

    Weis Markets Recalls Bakery Products Due to Potential Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to the potential presence of small metal fragments in the sugar topping.

    Product
    Gourmet Chocolate Chip Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0081-2017·2016-10-19

    Siemens Recalls Rubella IgM Assay Kits Due to False Positive Results

    Siemens is recalling specific lots of Rubella IgM assay kits because they may produce false positive or indeterminate results on certain analyzers.

    Product
    SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2017·2016-10-19

    Siemens Rubella IgM Assay Recalled for False Positive Results

    Siemens is recalling specific lots of Rubella IgM assays due to increased false positive and indeterminate results.

    Product
    SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0077-2017·2016-10-19

    R.W. Garcia Kale Crackers Recalled for Metal Fragments

    R.W. Garcia is recalling Kale Crackers because metal fragments were detected in the raw material. Consumers should stop eating the product.

    Product
    RW Garcia, 3 Seed.Graines, Kale Crackers, Craquelins de Kale, Gluten Free, Net Wt. 180g, Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., Las Vegas, NV 89115 and Lincoln, NC 28092, Distributed by Clean Foods, Ltd, Legion House, 75 Lower Road, Kenley, Surrey…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0070-2017·2016-10-19

    Medtronic O-arm O2 Surgical Imaging System Recalled for Calibration Errors

    Medtronic is recalling 14 O-arm O2 Surgical Imaging Systems because spatial calibration may be erroneous in navigated images, potentially affecting surgical accuracy.

    Product
    Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0043-2017·2016-10-19

    Doctor Kracker Pumpkin Seed Cheddar Crispbreads Recalled for Undeclared Milk

    Kracker Enterprises is recalling Doctor Kracker Pumpkin Seed Cheddar Crispbreads because the ingredient statement does not list milk, despite the product name containing Cheddar.

    Product
    Doctor Kracker Pumpkin Seed Cheddar Crispbreads Net Wt. 7 oz. (200g) in cardboard container.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-0056-2017·2016-10-19

    Gold Standard Baking Recalls Cheese Decadent Danish Due to Metal Shavings

    Gold Standard Baking is recalling Cheese Decadent Danish products because they may contain small metal shavings.

    Product
    Cheese Decadent Danish | NET WT 14 OZ (397g) | Gold Standard Baking, Chicago, IL 60632 | UPC: 087745050019
    Category
    Food
    Distribution
    Distributed nationwide