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.

10576–10600 of 22146

  • 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-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
  • HighNHTSA·24V519000·2024-08-07

    Nova Bus LFS windshield wiper blade alignment defect recall

    Nova Bus is recalling certain 2022-2023 LFS buses due to incorrectly aligned windshield wiper arms that can cause wiper blades to collide. Damaged blades reduce visibility and increase crash risk.

    Product
    NOVA BUS — 2022 NOVA BUS LFS
    Category
    Vehicle
    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-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-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 (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-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 (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-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-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 (Food)·F-1553-2024·2024-08-07

    Yelloh! Cookies & Cream Ice Cream Sandwich Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling Yelloh! Cookies & Cream Ice Cream Sandwiches due to possible contamination with Listeria monocytogenes. The recall affects approximately 8400 cases distributed nationwide.

    Product
    Yelloh! Cookies & Cream Ice Cream Sandwich 24 fl oz UPC 810038685090. Individually wrapped in plastic. 6 sandwiches packaged in a cardboard box, 12 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1606-2024·2024-08-07

    Dolcezza Roasted Strawberry Gelato recalled for possible Listeria contamination

    Totally Cool, Inc. is recalling Dolcezza Roasted Strawberry Gelato due to possible contamination with Listeria monocytogenes. The affected product was distributed nationwide.

    Product
    Dolcezza Roasted Strawberry Gelato 16 fl oz/1 pint, UPC 857838006106. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1599-2024·2024-08-07

    Dolcezza Sugar Cookie Dough Gelato recalled for possible Listeria contamination

    Totally Cool, Inc. is recalling Dolcezza Sugar Cookie Dough Gelato due to possible contamination with Listeria monocytogenes. Consumers should not consume the product and should discard it or return it to the retailer.

    Product
    Dolcezza Sugar Cookie Dough Gelato 16 fl oz/1 pint, UPC 857838006618. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1582-2024·2024-08-07

    LaSalle Chocolate Ice Cream recalled for possible Listeria contamination

    Totally Cool, Inc. is recalling LaSalle Chocolate Ice Cream due to possible Listeria monocytogenes contamination. The recall affects 5,604 cases distributed nationwide with Best By dates between November 18, 2024, and October 25, 2025.

    Product
    LaSalle Chocolate Ice Cream 16 fl oz/1 pint, UPC 671891374114. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0624-2024·2024-08-07

    Progesterone Injection Recalled for Glass Particulate Matter in Vials

    Eugia US LLC is recalling Progesterone Injection vials nationwide due to glass particles found in the product. Patients and healthcare providers should stop using the affected lot.

    Product
    PROGESTERONE — PROGESTERONE (PROGESTERONE)
    Category
    Drug
    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-1549-2024·2024-08-07

    Abilyn's Frozen Ice Cream Cake Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling Abilyn's Frozen Bakery Ice Cream Cake 'For the Love of Chocolate' due to possible Listeria monocytogenes contamination. The recall affects approximately 2,993 cases distributed nationwide with best-by dates from May 20, 2024 through May 28, 2025.

    Product
    Abilyn s Frozen Bakery Ice Cream Cake For the Love of Chocolate 6", UPC 851545008057. Packaged in cardboard box, 4 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1585-2024·2024-08-07

    LaSalle Cookie & Cream Ice Cream Recalled for Possible Listeria Contamination

    Totally Cool, Inc. recalls LaSalle Cookie & Cream Ice Cream for possible Listeria monocytogenes contamination. The product was distributed nationwide with best-by dates from November 18, 2024 to October 25, 2025.

    Product
    LaSalle Cookie & Cream Ice Cream 16 fl oz/1 pint, UPC 671891374138. 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-1607-2024·2024-08-07

    Dolcezza Peanut Butter Cup Gelato recalled for possible Listeria contamination

    Totally Cool, Inc. is recalling Dolcezza Peanut Butter Cup Gelato due to possible contamination with Listeria monocytogenes. The recall affects 8703 cases distributed nationwide with Best By Dates between 05/20/24 and 06/20/25.

    Product
    Dolcezza Peanut Butter Cup Gelato 16 fl oz/1 pint, UPC 857838006472. Packaged in paper containers, 8 containers per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1598-2024·2024-08-07

    Marco Green Tea White Chocolate Ice Cream Recalled for Possible Listeria Contamination

    Totally Cool, Inc. is recalling Marco Green Tea White Chocolate Ice Cream due to possible contamination with Listeria monocytogenes. The recall affects approximately 10,587 cases distributed nationwide with best-by dates from 06/07/24 to 12/11/25.

    Product
    Marco Green Tea White Chocolate Ice Cream 16 fl oz/1 pint, UPC 860006880521. 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-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