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.

10201–10225 of 27089

  • 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-1614-2024·2024-08-07

    Lunds & Byerlys pesto salmon rice recalled for undeclared fish and soy

    Lunds & Byerlys pesto salmon and lemon rice is mislabeled and contains undeclared fish (tilapia) and soybeans. The product is actually peach tilapia and edamame rice steamer.

    Product
    Lunds & Byerlys pesto salmon and lemon rice. UPC 18169-66396. Net Wt. 12 oz. (340.2g). Keep Refrigerated.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1560-2024·2024-08-07

    Jeni's Ice Cream Sandwiches Recalled for Possible Listeria Contamination

    Jeni's Ice Cream Sandwich Chocolate Silk Pie ice cream is being recalled nationwide due to possible Listeria monocytogenes contamination. Affected products have best-by dates from July 2025 to May 2026.

    Product
    Jeni's Ice Cream Sandwich Chocolate Silk Pie Ice Cream 3.5 fl oz UPC 858241006882. 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-1580-2024·2024-08-07

    Taharka Honey Graham Ice Cream recalled for possible Listeria contamination

    Totally Cool, Inc. is recalling Taharka Honey Graham Ice Cream due to possible contamination with Listeria monocytogenes. Approximately 2206 cases distributed nationwide are affected.

    Product
    Taharka Honey Graham Ice Cream 16 fl oz/1 pint, UPC 638455788442. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1586-2024·2024-08-07

    LaSalle Dulce De Leche Ice Cream Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling LaSalle Dulce De Leche Ice Cream due to possible Listeria monocytogenes contamination. The recall affects 6,043 cases distributed nationwide.

    Product
    LaSalle Dulce De Leche 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-1573-2024·2024-08-07

    Frozen Farms Strawberry Sorbet Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling The Frozen Farms Farm Crafted Strawberry Sorbet due to possible Listeria monocytogenes contamination. Affected products have best-by dates from September 5, 2025 through July 30, 2026.

    Product
    The Frozen Farms Farm Crafted Strawberry Sorbet 16 fl oz/1 pint, UPC 850023398017. 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 (Devices)·Z-2450-2024·2024-08-07

    Hip Replacement Prosthesis Recalled Due to Increased Postoperative Fracture Risk

    Zimmer hip replacement prostheses are recalled due to increased risk of postoperative femoral fracture. Affected devices are distributed nationwide; patients should consult their surgeon.

    Product
    CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 00811400310 00811400318 00811400330 00811400400 008114
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1557-2024·2024-08-07

    Frozen Farmer ice cream sandwich recalled for possible Listeria contamination

    Frozen Farmer ice cream sandwiches are being recalled nationwide due to possible Listeria monocytogenes contamination. Consumers should not consume the product if they have purchased it.

    Product
    The Frozen Farmer Santa's Cookies Ice Cream Cookie Sandwich the Elf On the Shelf 4 fl oz UPC 850023398178. Individually wrapped in plastic, 4 sandwiches packaged in a cardboard box, 24 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-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-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 (Devices)·Z-2416-2024·2024-08-07

    SlideView VS200 slide viewer laser shutter malfunction recall

    The SlideView VS200 slide viewer has a broken laser fuse caused by a short circuit from a poorly positioned cable. This prevents the shutter from operating properly, leaving it stuck in an open or closed position.

    Product
    SlideView VS200 slide viewer,
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-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 (Food)·F-1608-2024·2024-08-07

    Dolcezza Peanut Butter Stracciatella Gelato Recalled for Possible Listeria Contamination

    Dolcezza Peanut Butter Stracciatella Gelato is being recalled due to possible contamination with Listeria monocytogenes. The recall affects 2,355 cases distributed nationwide with best-by dates between May 20, 2024 and June 20, 2025.

    Product
    Dolcezza Peanut Butter Stracciatella Gelato 16 fl oz/1 pint, UPC 857838006090. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1554-2024·2024-08-07

    Yelloh! Ice Cream Sandwiches Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling Yelloh! Chocolate Chip Ice Cream Sandwiches nationwide for possible Listeria monocytogenes contamination. Do not consume; dispose of or return the product (codes 6T3115–6T4171).

    Product
    Yelloh! Chocolate Chip Ice Cream Sandwich With Vanilla Ice Cream 24 fl oz UPC 810038685106. Individually wrapped in plastic. 6 sandwiches packaged in cardboard box, 12 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1611-2024·2024-08-07

    Dolcezza Vanilla Bean Ice Cream Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling Dolcezza Vanilla Bean ice cream due to possible contamination with Listeria monocytogenes. The recall affects 3,669 cases distributed nationwide with best-by dates between May 20, 2024 and June 20, 2025.

    Product
    Dolcezza Vanilla Bean 16 fl oz/1 pint, UPC 857838006168. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2455-2024·2024-08-07

    Clinical Chemistry Analyzer Software Bugs May Cause Erroneous Patient Results

    Beckman Coulter's DxC 500 AU analyzer has two software bugs that may cause erroneous patient results due to misreported calibrations or expired reagents. No injuries or illnesses have been reported.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-1555-2024·2024-08-07

    Cumberland Farms ice cream sandwich recalled for possible Listeria contamination

    Totally Cool, Inc. is recalling Cumberland Farms Farmhouse Premium Ice Cream Sandwiches (Rich Vanilla, 4 fl oz) due to possible Listeria monocytogenes contamination. Approximately 2,436 cases with best-by dates from 11/30/25 to 12/04/25 were distributed nationwide.

    Product
    Cumberland Farms Farmhouse Premium Ice Cream Sandwich, Rich Vanilla, 4 fl oz UPC 42704010046. Individually wrapped in plastic, 24 units per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1578-2024·2024-08-07

    Chipwich Vanilla Chocolate Chip Ice Cream recalled due to possible Listeria contamination

    Totally Cool, Inc. is recalling Chipwich Vanilla Chocolate Chip Ice Cream (5977 cases) nationwide due to possible Listeria monocytogenes contamination. Affected products have best by dates from July 25, 2024 to January 27, 2025.

    Product
    Chipwich Vanilla Chocolate Chip Ice Cream 16 fl oz/1 pint, UPC 810493032019. Packaged in paper containers, 8 containers per case
    Category
    Food
    Distribution
    Distributed nationwide