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.

10601–10625 of 22146

  • HighFDA (Food)·F-1570-2024·2024-08-07

    Chipwich Ice Cream Sandwich Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling Chipwich Double Chocolate Chip Ice Cream Sandwiches due to possible Listeria monocytogenes contamination. The recall affects 6,722 cases distributed nationwide with best-by dates from February 23, 2025 to December 21, 2025.

    Product
    Chipwich Double Chocolate Chip Ice Cream Sandwich 4 fl oz, UPC 810493030329. Individually plastic wrapped sandwiches packaged in a carboard box. 12 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1589-2024·2024-08-07

    LaSalle Vanilla Fudge Ice Cream Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling LaSalle Vanilla Fudge Ice Cream due to possible contamination with Listeria monocytogenes. The affected product was distributed nationwide.

    Product
    LaSalle Vanilla Fudge Ice Cream 16 fl oz/1 pint, UPC 671891374206. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1566-2024·2024-08-07

    Yelloh! Vanilla Fudge Sundae Cones recalled for possible Listeria contamination

    Totally Cool, Inc. is recalling Yelloh! Vanilla Fudge Sundae Cones (4 fl oz, UPC 810038684901) due to possible contamination with Listeria monocytogenes. Approximately 5,223 cases were distributed nationwide.

    Product
    Yelloh! Vanilla Fudge Sundae Cones 4 fl oz UPC 810038684901. 12 cones wrapped in paper, packaged in cardboard box, 8 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1596-2024·2024-08-07

    Marco Vanilla Chai Ice Cream recalled for possible Listeria contamination

    Marco Vanilla Chai Ice Cream 16 fl oz is being recalled due to possible contamination with Listeria monocytogenes. The affected products have best-by dates between 06/07/24 and 12/11/25.

    Product
    Marco Vanilla Chai Ice Cream 16 fl oz/1 pint, UPC 86000199286. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1605-2024·2024-08-07

    Dolcezza Mascarpone & Berries Gelato Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling Dolcezza Mascarpone & Berries Gelato nationwide due to possible Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    Dolcezza Mascarpone & Berries Gelato 16 fl oz/1 pint, UPC 857838006083. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1546-2024·2024-08-07

    Friendly's Strawberry Krunch Ice Cream Cake recalled for possible Listeria contamination

    Friendly's Strawberry Krunch Ice Cream Cake is being recalled due to possible Listeria monocytogenes contamination. Approximately 86,540 cases distributed nationwide are affected.

    Product
    Friendly's Strawberry Krunch Ice Cream Cake 40 fl oz, UPC 29839413065. Packaged in cardboard box, 4 boxes per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1567-2024·2024-08-07

    Vanilla Nut Sundae Cones Recalled for Possible Listeria Contamination

    Yelloh! Classic Vanilla Nut Sundae Cones are recalled nationwide due to possible contamination with Listeria monocytogenes. Consumers should dispose of or return affected packages.

    Product
    Yelloh! Classic Vanilla Nut Sundae Cones 4 fl oz UPC 810038684895. 24 cones wrapped in paper, packaged in cardboard box, 8 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2451-2024·2024-08-07

    Capio SLIM Suture Capturing Device may fail to catch sutures consistently

    Boston Scientific is recalling some lots of Capio SLIM Suture Capturing Devices because they may not consistently catch sutures during surgery, potentially requiring prolonged procedures or additional medical intervention.

    Product
    Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1571-2024·2024-08-07

    Amafruit Organic Acai Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling Amafruit Superfruits organic acai in 3-gallon tubs nationwide due to possible Listeria monocytogenes contamination. Approximately 42,273 cases are affected.

    Product
    Amafruit Superfruits from the Amazon Organic Acai packaged in 3 gallon plastic tubs, UPC 855738002181.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1584-2024·2024-08-07

    LaSalle Cherry Vanilla Ice Cream Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling LaSalle Cherry Vanilla Ice Cream for possible Listeria monocytogenes contamination. The affected product was distributed nationwide.

    Product
    LaSalle Cherry Vanilla Ice Cream 16 fl oz/1 pint, UPC 671891374107. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1565-2024·2024-08-07

    Yelloh! Pecan Praline Sundae Cones recalled for possible Listeria contamination

    Yelloh! Pecan Praline Sundae Cones (4 fl oz) manufactured by Totally Cool, Inc. are being recalled due to possible contamination with Listeria monocytogenes.

    Product
    Yelloh! Pecan Praline Sundae Cones 4 fl oz UPC 810038684925. 12 cones wrapped in paper, packaged in cardboard box, 8 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2457-2024·2024-08-07

    Arctic Sun Temperature Management System software failure may disable critical safety alarms

    Arctic Sun Temperature Management Systems may fail to reach target temperature and critically fail to alert clinicians. The software defect affects approximately 10,507 units worldwide and risks hypothermia or hyperthermia.

    Product
    Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1561-2024·2024-08-07

    Jeni's Frozen Dessert Sandwiches Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling Jeni's Frozen Dessert Sandwiches Key Lime Pie due to possible Listeria monocytogenes contamination. The affected products were distributed nationwide.

    Product
    Jeni's Frozen Dessert Sandwiches Key Lime Pie 3.5 fl oz UPC 858241006875. Individually wrapped in plastic and packaged in cardboard box, 3 sandwiches per box. 8 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2452-2024·2024-08-07

    Boston Scientific Capio SLIM Device May Fail During Surgical Procedures

    Some lots of the Capio SLIM suture capturing device may fail to consistently catch sutures during surgery, potentially requiring extended procedures or additional medical intervention.

    Product
    Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1583-2024·2024-08-07

    LaSalle Butter Pecan Ice Cream recalled for possible Listeria contamination

    Totally Cool, Inc. is recalling LaSalle Butter Pecan Ice Cream nationwide due to possible Listeria monocytogenes contamination. Affected consumers should return or discard the product.

    Product
    LaSalle Butter Pecan Ice Cream 16 fl oz/1 pint, UPC 671891374091. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1564-2024·2024-08-07

    Hershey's Ice Cream Cones Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling 197,701 cases of Hershey's Ice Cream Cookies and Cream Cones due to possible Listeria monocytogenes contamination. Affected codes 3174–4047 were distributed nationwide.

    Product
    Hershey's Ice Cream Cookies and Cream Ice Cream Cone 4 fl oz UPC 24682313067. Individually packaged in paper. 3 sandwiches per box. 24 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1562-2024·2024-08-07

    Jeni's Ice Cream Sandwiches Mint Chocolate Truffles recalled for possible Listeria contamination

    Totally Cool, Inc. is recalling Jeni's Ice Cream Sandwiches Mint Chocolate Truffles nationwide due to possible contamination with Listeria monocytogenes. No illnesses have been reported to date.

    Product
    Jeni's Ice Cream Sandwiches Mint Chocolate Truffles 3.5 fl oz UPC 858241006868. Individually wrapped in plastic and packaged in cardboard box, 3 sandwiches per box. 8 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1543-2024·2024-08-07

    Hill Country Fare Mustard Potato Salad recalled due to plastic contamination

    Reser's Fine Foods is recalling Hill Country Fare Mustard Potato Salad because some containers may contain plastic foreign material. Consumers in Texas should not consume this product.

    Product
    Hill Country Fare Mustard Potato Salad refrigerated product is packaged in clear square plastic container with printed white plastic lid, net 48oz (3lb) 1.36 KG. UPC 4122003165. Distributed by H-E-B, San Antonio, TX 78204. There are 6 containers per case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1551-2024·2024-08-07

    Hershey's ice cream sheet cake recalled for possible Listeria contamination

    Totally Cool, Inc. is recalling Hershey's ice cream sheet cake due to possible contamination with Listeria monocytogenes. The FDA Class II recall affects 14,180 cases distributed nationwide.

    Product
    Hershey s Ice Cream Vanilla & Chocolate Flavored Ice Cream Sheet Cake 110 fl oz, UPC 24682060152. Packaged in cardboard box, 3 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1594-2024·2024-08-07

    Marco Turkish Mocha Ice Cream Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling Marco Turkish Mocha Ice Cream 16 fl oz due to possible Listeria monocytogenes contamination. Consumers should not consume affected products.

    Product
    Marco Turkish Mocha Ice Cream 16 fl oz/1 pint, UPC 860001992885. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1581-2024·2024-08-07

    Taharka Key Lime Pie Ice Cream recalled for possible Listeria contamination

    Totally Cool, Inc. is recalling Taharka Key Lime Pie Ice Cream (16 fl oz) due to possible Listeria monocytogenes contamination. Consumers should not consume the product and should return it to the retailer for a refund.

    Product
    Taharka Key Lime Pie Ice Cream 16 fl oz/1 pint, UPC 638455789074. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1559-2024·2024-08-07

    Ice Cream Sandwiches Recalled Due to Possible Listeria Contamination

    Totally Cool, Inc. is recalling Marco Sweets & Spices Dulce De Leche Ice Cream Sandwiches due to possible Listeria monocytogenes contamination. Approximately 1103 cases were distributed nationwide.

    Product
    Marco Sweets & Spices Dulce De Leche Ice Cream Sandwiches 3.8 fl oz UPC 860010682753. Individually wrapped in plastic. 3 sandwiches packaged in cardboard box, 8 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1597-2024·2024-08-07

    Marco Peanut Butter Caramel Ice Cream Recalled Due to Listeria Risk

    Totally Cool, Inc. is recalling Marco Peanut Butter Caramel Ice Cream nationwide due to possible Listeria monocytogenes contamination. Consumers should not consume the product and should check their freezers for affected items.

    Product
    Marco Peanut Butter Caramel Ice Cream 16 fl oz/1 pint, UPC 860001992878. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1593-2024·2024-08-07

    Marco Dulce De Leche & Cookies Ice Cream recalled for possible Listeria contamination

    Totally Cool, Inc. is recalling Marco Dulce De Leche & Cookies Ice Cream due to possible Listeria monocytogenes contamination. Approximately 17,633 cases were distributed nationwide.

    Product
    Marco Dulce De Leche & Cookies Ice Cream 16 fl oz/1 pint, UPC 860006880514. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1548-2024·2024-08-07

    Frozen ice cream cake recalled for possible Listeria monocytogenes contamination

    Totally Cool, Inc. is recalling Abilyn's Frozen Bakery Ice Cream Cake Cookies 'n Cream due to possible Listeria monocytogenes contamination. Affected products were distributed nationwide and have Best By dates between May 20, 2024 and May 28, 2025.

    Product
    Abilyn s Frozen Bakery Ice Cream Cake Cookies 'n Cream 6", UPC 851545008040. Packaged in cardboard box, 4 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide