The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

10351–10375 of 27206

  • 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-1579-2024·2024-08-07

    Mint chocolate chip ice cream recalled for possible listeria contamination

    Chipwich Mint Chocolate Chip Ice Cream (16 fl oz) is being recalled nationwide due to possible contamination with Listeria monocytogenes. Affected products have best-by dates from July 25, 2024, to January 27, 2025.

    Product
    Chipwich Mint Chocolate Chip Ice Cream 16 fl oz/1 pint, UPC 810493032026. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1518-2024·2024-08-07

    Campanelle Pasta Recall Due to Potential Mold Growth

    PASTAURORA LLC is recalling Campanelle vegan dried pasta distributed in Washington due to potential mold growth contamination.

    Product
    Campanelle (vegan) Dried, net wt. 10oz. in clear package with green/back printings on whie label. UPC 850049624022.
    Category
    Food
    Distribution
    1 state
  • 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
  • HighFDA (Food)·F-1577-2024·2024-08-07

    Frozen Farms Santa's Cookies Ice Cream recalled for possible Listeria contamination

    Totally Cool, Inc. recalls The Frozen Farms Santa's Cookies Ice Cream due to possible Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    The Frozen Farms Santa's Cookies Ice Cream Vanilla Ice Cream With Red and Green Sugar Cookie Crumbles Dessert 16 fl oz/1 pint, UPC 850023398161. Packaged in paper containers, 8 containers per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1544-2024·2024-08-07

    Corey B's Oh Baby BBQ Sauce recalled for undeclared wheat allergen

    Corey B's Oh Baby BBQ Sauce is recalled due to undeclared wheat allergen. Consumers with wheat allergies should not consume the product.

    Product
    Corey B's Oh Baby BBQ Sauce packaged in 12.6oz glass flask - 12 bottles per case
    Category
    Food
    Distribution
    0 states
  • 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-1572-2024·2024-08-07

    Amafruit Superfruits Recalled for Possible Listeria Contamination Nationwide

    Totally Cool, Inc. is recalling Amafruit Superfruits from the Amazon Dragon Fruit due to possible Listeria monocytogenes contamination. The product has been distributed nationwide; consumers should discard or return affected lots.

    Product
    Amafruit Superfruits from the Amazon Dragon Fruit. Packaged in 3 gallon plastic tubs, UPC 855738002242.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1574-2024·2024-08-07

    Frozen Farms Raspberry Sorbet Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling The Frozen Farms Farm Crafted Raspberry Sorbet due to possible Listeria monocytogenes contamination. The affected product was distributed nationwide.

    Product
    The Frozen Farms Farm Crafted Rasberry Sorbet 16 fl oz/1 pint, UPC 850023398116. Packaged in paper containers, 8 containers 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-1552-2024·2024-08-07

    Hershey's Ice Cream Cookies & Cream Polar Bear Sandwiches Recalled for Listeria Risk

    Totally Cool, Inc. is recalling Hershey's Ice Cream Cookies & Cream Polar Bear Sandwiches nationwide due to possible Listeria monocytogenes contamination affecting 197,701 cases.

    Product
    Hershey s Ice Cream Cookies & Cream Polar bear Premium Ice Cream Sandwich 45 oz/4 fl oz UPC 24682312855. Individually wrapped in plastic and packaged in cardboard box, 24 units per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1603-2024·2024-08-07

    Dolcezza Dark Chocolate Gelato Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling Dolcezza Dark Chocolate Gelato due to possible Listeria monocytogenes contamination. Affected products have Best By dates between May 20, 2024 and June 20, 2025.

    Product
    Dolcezza Dark Chocolate Gelato 16 fl oz/1 pint, UPC 857838006083. 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-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-1569-2024·2024-08-07

    Chipwich Ice Cream Sandwiches recalled for possible Listeria monocytogenes contamination

    Chipwich Vanilla Chocolate Chip Ice Cream Sandwiches sold in 3, 10, and 24-packs are recalled due to possible Listeria monocytogenes contamination. Approximately 113,315 cases distributed nationwide are affected.

    Product
    Chipwich Vanilla Chocolate Chip Ice Cream Sandwich 4 fl oz sold as 3-pack, 10-pack, and 24 (single serve) pack. Sandwiches individually wrapped in plastic. Product packaged in cardboard boxes. UPCs 810493034013, 810493035010, and 810493030022. 12 boxes/8 boxes/24 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-1591-2024·2024-08-07

    Vanilla Raspberry Ice Cream Recalled for Possible Listeria Contamination

    Totally Cool, Inc. recalls LaSalle Vanilla Raspberry Ice Cream for possible Listeria monocytogenes contamination. Nationwide distribution affected; consumers should discard or return the product to point of purchase.

    Product
    LaSalle Vanilla Raspberry Ice Cream 16 fl oz/1 pint, UPC 671891374244. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1587-2024·2024-08-07

    LaSalle Strawberry Ice Cream Recalled for Possible Listeria Contamination

    LaSalle Strawberry Ice Cream has been recalled due to possible contamination with Listeria monocytogenes. The recall affects 4,148 cases distributed nationwide with Best By dates between November 18, 2024 and October 25, 2025.

    Product
    LaSalle Strawberry Ice Cream 16 fl oz/1 pint, UPC 671891374152. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1595-2024·2024-08-07

    Marco Moroccan Honey Nut Ice Cream Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling Marco Moroccan Honey Nut Ice Cream nationwide due to possible contamination with Listeria monocytogenes. Approximately 14,387 cases with best-by dates June 2024 to December 2025 may be affected; no illnesses reported.

    Product
    Marco Moroccan Honey Nut Ice Cream 16 fl oz/1 pint, UPC 860006880407. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1590-2024·2024-08-07

    LaSalle Mango & Cream Ice Cream Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling LaSalle Mango & Cream Ice Cream due to possible contamination with Listeria monocytogenes. The recalled product was distributed nationwide with Best By dates between November 18, 2024, and October 25, 2025.

    Product
    LaSalle Mango & Cream Ice Cream 16 fl oz/1 pint, UPC 671891374169. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1612-2024·2024-08-07

    Frozen Ice Cream Recalled for Possible Listeria Contamination

    Totally Cool, Inc. recalls Abilyn's Frozen Bakery Cookie Dough Ice Cream due to possible contamination with Listeria monocytogenes. Consumers should not consume affected products.

    Product
    Abilyn's Frozen Bakery Cookie Dough Ice Cream UPC 851545008071. Packaged in cardboard box, 4 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2024·2024-08-07

    Blood Culture Identification Panel May Produce False Positive Results

    The BIOFIRE BCID2 Panel may produce false positive Serratia marcescens results when used with certain culture media bottles, potentially leading to inappropriate changes in patient therapy.

    Product
    BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1568-2024·2024-08-07

    Yelloh! Chip & Mint Sundae Cones Recalled Due to Listeria Contamination Risk

    Yelloh! Chip & Mint Sundae Cones 4 fl oz are being recalled due to possible Listeria monocytogenes contamination. Approximately 3,817 cases were distributed nationwide.

    Product
    Yelloh! Chip & Mint Sundae Cones 4 fl oz UPC 810038684918. 12 cones wrapped in paper, packaged in cardboard box, 8 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1558-2024·2024-08-07

    Ice cream sandwiches recalled for possible Listeria monocytogenes contamination

    Marco Sweets & Spices Vanilla Chai Ice Cream Sandwiches are recalled for possible Listeria monocytogenes contamination. The recall affects 885 cases nationwide with best-by dates between November 28–29, 2025.

    Product
    Marco Sweets & Spices Vanilla Chai Ice Cream Sandwiches 3.8 fl oz UPC 860010682739. Individually wrapped in plastic. 3 sandwiches packaged in cardboard box, 8 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide