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.

27051–27075 of 50462

  • HighFDA (Food)·F-0337-2019·2018-11-07

    Sargento IQF Veggie Burgers Recalled for Potential Listeria and Salmonella

    Sargento Foods is recalling specific IQF Veggie Burgers due to potential Listeria monocytogenes or Salmonella contamination. The affected products were distributed in Florida, Ohio, and Wisconsin.

    Product
    Sargento IQF Veggie Burger. Product 10001725 6/4 lb., and Product 4610035085 6/4lb. Keep Frozen. Manufactured by Sargento Foods, Inc., Plymouth, WI 53073
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0303-2019·2018-11-07

    Philips CT Scanner Software Recall for Misleading Calcium Score Reports

    Philips is recalling 145 CT scanners because software version 4.2.0 generates confusing calcium score reports that may lead to patient mistreatment.

    Product
    Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2019·2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 158,163 units of Exactamix Empty EVA Bags because they may leak after being used for compounding.

    Product
    EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0310-2019·2018-11-07

    Philips CT Scanner Software Recall for Misleading Calcium Score Reports

    Philips is recalling Ingenuity Core 128 CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.

    Product
    Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0333-2019·2018-11-07

    Buddy's Kitchen Recalls Beef Barbacoa Panini Focaccia for Listeria or Salmonella Risk

    Buddy's Kitchen is recalling Beef Barbacoa on Panini Focaccia due to potential Listeria or Salmonella contamination linked to a McCain Foods recall.

    Product
    Beef Barbacoa on Panini Focaccia, Item 70659. Net Weight 14.85 lbs. 36 - 6.60 oz. portions. Keep Frozen. For institutional use only. Buddy's Kitchen, Inc., Burnsville, MN 55337
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-0365-2019·2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 136,800 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0075-2019·2018-11-07

    Foodstirs Organic Mug Cake Mix Recalled for Undeclared Milk Allergen

    Foodstirs is recalling Organic Minute Mug Cake Mix Celebration Confetti 4-packs because individual pouches fail to declare milk as an allergen.

    Product
    Foodstirs Modern Baking; Organic Minute Mug Cake Mix Celebration Confetti - 4 - 2.54 oz. (72g) Pouches per carton -Carton Net Wt. 10.16 oz. (288g) Carton UPC; 816524 02789 Master case UPC: 816524 020796
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0366-2019·2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 456,071 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0345-2019·2018-11-07

    Allsup's Green Chile Burritos Recalled for Potential Contamination

    Ajinomoto Windsor Inc. is recalling Allsup's Hatch Green Chile & Cheese Burritos due to potential Salmonella or Listeria contamination in diced green peppers.

    Product
    Allsup's Hatch Green Chile & Cheese Burrito, 72/4.5 oz burritos per case
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0364-2019·2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 110,134 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0111-2019·2018-11-07

    Sprayology Recalls AllergEase Homeopathic Oral Spray Due to CGMP Deviations

    Sprayology is recalling 4,153 bottles of AllergEase Homeopathic Oral Spray because manufacturing conditions could result in possible microbial contamination.

    Product
    AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0003-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2019·2018-11-07

    Philips IQon Spectral CT Software Recall for Misleading Calcium Score Reports

    Philips is recalling IQon Spectral CT scanners with specific software versions because the Calcium Score report provides confusing and potentially misleading plaque analysis data.

    Product
    IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0117-2019·2018-11-07

    Sprayology Recalls Arnica Power Homeopathic Oral Spray Due to CGMP Deviations

    Sprayology is recalling 3,531 bottles of Arnica Power Homeopathic Oral Spray due to manufacturing deviations that could result in microbial contamination.

    Product
    Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0032-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0360-2019·2018-11-07

    Caito Foods Recalls Stuffed Mushrooms for Listeria and Salmonella Risk

    Caito Foods LLC is recalling 64 units of Southwest Stuffed Mushrooms due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    MUSHROOM PRTBELA SOUTHWEST STUFFED; 8oz. Black Foam Over-wrapped Trays; Keep Refrigerated; UPC 0884853631037
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0358-2019·2018-11-07

    Caito Foods Recalls Stuffed Crimini Mushrooms Due to Pathogen Contamination Risk

    Caito Foods LLC is recalling 204 units of 7-ounce stuffed crimini mushrooms due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    MUSHROOM CRIMINI SOUTHWEST STUFFED; 7oz. Black Foam Over-wrapped Trays; Keep Refrigerated; UPC 0884853631044
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0311-2019·2018-11-07

    Philips Brilliance iCT SP CT Scanners Recalled for Misleading Calcium Score Reports

    Philips is recalling 626 Brilliance iCT SP CT scanners because specific software versions generate confusing calcium score reports that may lead to patient mistreatment.

    Product
    Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0351-2019·2018-11-07

    Trader Joe's Hummus Recalled for Potential Salmonella and Listeria Contamination

    Bakkavor Foods USA is recalling Trader Joe's Hummus quartets due to potential Salmonella and Listeria monocytogenes contamination. Consumers should discard the product.

    Product
    Trader Joe's Hummus quartet; 20 oz. plastic container; Spicy Hummus Roasted Garlic Hummus, Regular Hummus and Tomato Basil Hummus. Perishable, Keep Refrigerated. SKU 39570
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0430-2019·2018-11-07

    Portland Chocolate Recalls 60% Dark Chocolate Chips Due to Peanut Cross-Contamination

    Portland Chocolate Company LLC is recalling 60% Dark Chocolate Chips due to cross-contamination with peanut. The product was distributed in Oregon and California.

    Product
    60% Dark Chocolate Chips, packaged in poly-lined cardboard boxes, net wt. 30 lbs. The label is read in parts: "*** Pitch Dark Chocolate*** 60% Dark Chocolate ***Bulk 30lbs *** Produced in a facility that also processes: Peanuts, tree nuts, dairy ***".
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0307-2019·2018-11-07

    Philips CT Scanner Software Recall for Misleading Calcium Score Reports

    Philips is recalling 145 CT scanners with software version 4.2.0 because the Calcium Score report may display confusing plaque analyses, potentially leading to patient mistreatment.

    Product
    Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0357-2019·2018-11-07

    Caito Foods Recalls Ancho Chili Cauliflower Rice for Pathogen Risk

    Caito Foods LLC is recalling 605 units of Ancho Chili & Corn Cauliflower Rice due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    ANCHO CHILI & CORN CAULIFLOWER RICE; 12oz. Plastic Clamshell; Keep Refrigerated; UPC 0826766185900
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0313-2019·2018-11-07

    BD Max Instrument Recall for False Positive Candida Results

    Becton Dickinson is recalling 49 refurbished BD Max instruments due to a confirmed trend of false positive Candida glabrata results when Trichomonas vaginalis is present.

    Product
    BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0305-2019·2018-11-07

    Philips Brilliance iCT Scanners Recalled for Misleading Calcium Score Reports

    Philips is recalling Brilliance iCT scanners because software errors create confusing calcium score reports that may lead to patient mistreatment.

    Product
    Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0338-2019·2018-11-07

    Sargento IQF Goat Cheese Recalled for Potential Listeria or Salmonella

    Sargento Foods is recalling IQF Goat Cheese with Tomatoes and Kale due to potential Listeria monocytogenes or Salmonella contamination.

    Product
    Sargento IQF Goat Cheese with Tomatoes and Kale. Product 10001148 and 4610034611 1/28 lb., Net Wt 28.000 lbs. Keep Frozen. Manufactured by Sargento Foods, Inc., Plymouth, WI 53073
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0331-2019·2018-11-07

    Buddy's Kitchen Mushroom & Thyme Flatbread Pizza Recalled for Contamination Risk

    Buddy's Kitchen is recalling Mushroom & Thyme Flatbread Pizza due to potential Listeria or Salmonella contamination linked to a McCain Foods recall.

    Product
    Mushroom & Thyme Flatbread Pizza, Item 70610. Net Weight 7.65 lbs. 48-2.55 oz. portions. Keep Frozen. For institutional use only. Buddy's Kitchen, Inc., Burnsville, MN 55337
    Category
    Food
    Distribution
    8 states