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.

26951–26975 of 50462

  • HighFDA (Drugs)·D-0236-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 50mg pellets nationwide due to a lack of assurance of sterility.

    Product
    Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-150-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2019·2018-11-14

    GE Healthcare Recalls Centricity Universal Viewer Due to Synchronization Failure

    GE Healthcare is recalling 73 Centricity Universal Viewer units because a synchronization failure may affect the display of medical images.

    Product
    Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-0377-2019·2018-11-14

    Request Foods Recalls Evol Risotto for Listeria and Salmonella Contamination

    Request Foods Incorporated is recalling Evol Truffle Parmesan & Portabella Risotto because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Evol Truffle Parmesan & Portabella Risotto 18oz UPC 91627 00786 Frozen 6, 18oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0389-2019·2018-11-14

    Kashi Fire Roasted Quinoa Bowl Recalled for Listeria and Salmonella Risk

    Request Foods Incorporated is recalling Kashi Fire Roasted Quinoa Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Kashi, Fire Roasted Quinoa Bowl 9.5oz. UPC 18627 10769 Frozen 8, 9.5oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0382-2019·2018-11-14

    Request Foods Recalls Udi's Broccoli & Kale Lasagna for Contamination Risk

    Request Foods Incorporated is recalling Udi's Broccoli & Kale Lasagna because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Udi's, Broccoli & Kale Lasagna 227g UPC 98997 80842 Frozen 6 units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2019·2018-11-14

    Zimmer Biomet RapidFlap SpinDown Clamp Recalled for Assembly Error

    Zimmer Biomet is recalling 23,726 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0424-2019·2018-11-14

    Kroger Frozen Alaskan Salmon Bites Recalled for Listeria and Salmonella Risk

    Trident Seafoods is recalling Kroger brand frozen Alaskan Salmon Bites due to potential contamination with Listeria monocytogenes or Salmonella in the vegetable ingredient.

    Product
    Kroger brand. Frozen non-ready to eat Alaskan Salmon Bites, Net Wt 12 oz (340 g). SKU # 83091. UPC on retail package: 0 11110 83091 3. UPC on master case: 1 00 11110 83091 0 The label is read in parts: "***Kroger ***multi-grain Breaded ALASKAN SALMON BITES ***COOKING…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0368-2019·2018-11-14

    Tropical Dreams Vegan Chocolate Ice Cream Recalled for Undeclared Soy Oil

    Edney and Sellers, Ltd. is recalling Tropical Dreams Super Premium Ice Cream Vegan Chocolate because soy oil was not declared on the package label.

    Product
    Tropical Dreams Super Premium Ice Cream Vegan Chocolate ; Pint container; UPC 685450676526 Ingredients: Coconut milk, organic sugar, water, cocoa powder, malt syrup. . Food Allergy warning: This product was prepared at facilities where milk, eggs, wheat, peanuts, tree…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0370-2019·2018-11-14

    Village Baker Cinnamon Chip Sourdough Recalled for Undeclared Allergens

    Artisan Baking Company is recalling Village Baker Cinnamon Chip Sourdough because the label fails to declare milk powder and soy lecithin.

    Product
    Village Baker SPECIALTY ARTISAN BREADS CINNAMON CHIP SOURDOUGH. The product is whole sliced loaves packed in clear plastic bags that are closed with a twist tie. The net weight is 1.5 lbs. The loaves were sold as individual units. The UPC is 6 42739 00121 9. The product's…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0384-2019·2018-11-14

    Udi's Pesto Tortellini Recalled for Listeria and Salmonella Contamination

    Request Foods Incorporated is recalling Udi's Pesto Tortellini because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Udi's Pesto Tortellini 8 oz. UPC 98997 80974 Frozen 6, 8oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0390-2019·2018-11-14

    Kashi Pesto Chickpea Quinoa Bowls Recalled for Listeria and Salmonella

    Request Foods Incorporated is recalling Kashi Pesto Chickpea Quinoa Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Kashi, Pesto Chickpea Quinoa Bowl 9oz. UPC 18627 10771 Frozen 8, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2019·2018-11-14

    AROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure

    AROA Biosurgery is recalling 8,853 boxes of Endoform Dermal Template 2x2 due to a potential pouch seal failure that could compromise sterility.

    Product
    Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0376-2019·2018-11-14

    Request Foods Recalls Evol Portabello Goat Cheese Ravioli for Contamination Risk

    Request Foods Incorporated is recalling Evol Portabello Goat Cheese Ravioli because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Evol Portabello Goat Cheese Ravioli 18oz UPC 91627 00789 Frozen 6, 18oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0390-2019·2018-11-14

    Cordis POWERFLEX PRO PTA Dilatation Catheter Recalled for Burst Strength Failure

    Cordis Corporation is recalling 162 units of POWERFLEX PRO PTA Dilatation Catheters because they may not meet internal manufacturing burst strength specifications.

    Product
    Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0397-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamp Due to Assembly Error

    Zimmer Biomet is recalling 3,246 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2019·2018-11-14

    Recall of Testosterone 12.5mg Pellet due to Sterility Concerns

    Qualgen, LLC is recalling Testosterone 12.5mg pellets nationwide because the sterility of the product cannot be assured. Consumers should stop using the affected lots and contact the manufacturer or pharmacist.

    Product
    Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0388-2019·2018-11-14

    Kashi Mayan Harvest Bake Bowl Recalled for Listeria and Salmonella Risk

    Request Foods Incorporated is recalling Kashi Mayan Harvest Bake Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Kashi, Mayan Harvest Bake Bowl 10oz. UPC 18627 10605 Frozen 8, 10oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0391-2019·2018-11-14

    Request Foods Recalls Kashi Coconut Lemongrass Rice Bowls Due to Contamination Risk

    Request Foods Incorporated is recalling Kashi Coconut Lemongrass Rice Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Kashi, Coconut Lemongrass Rice Bowl 9oz. UPC 18627 10765 Frozen 8, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0234-2019·2018-11-14

    Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

    Qualgen, LLC is recalling specific lots of Testosterone 25 mg pellets nationwide because the company lacks assurance of sterility for these products.

    Product
    Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0397-2019·2018-11-14

    Request Foods Recalls Curry Jackfruit Bowls Due to Listeria and Salmonella Risk

    Request Foods Incorporated is recalling The Jackfruit Company Curry Jackfruit Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    The Jackfruit Company Curry Jackfruit Bowl 9oz. UPC 59806 00344 Frozen 6, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0392-2019·2018-11-14

    Kashi Creamy Cashew Noodle Bowl Recalled for Listeria and Salmonella Risk

    Request Foods Incorporated is recalling Kashi Creamy Cashew Noodle Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Kashi, Creamy Cashew Noodle Bowl 8oz. UPC 18627 10767 Frozen 8, 8oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide