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.

18376–18400 of 50407

  • HighFDA (Devices)·Z-0417-2022·2021-12-29

    Surgical Navigation Tracker Subject to Weld Failure and Navigation Inaccuracy

    A surgical navigation tracker used in neurosurgery may experience weld failure, leading to navigation inaccuracy, prolonged procedure time, and potential tissue injury. 98 affected units were distributed across US and international healthcare facilities.

    Product
    Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Drugs)·D-0290-2022·2021-12-29

    Rompe Pecho Cold & Flu Syrup Recalled for Microbial Contamination

    Efficient Laboratories is recalling Rompe Pecho CF Cold & Flu Advanced Formula syrup due to microbial contamination of the non-sterile product. The recall affects 10,833 bottles distributed nationwide.

    Product
    ROMPE PECHO — ROMPE PECHO (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0416-2022·2021-12-29

    Philips Allura Xper FD Ceiling Monitors Risk Falling Due to Loose Screws

    Set screws on ceiling-mounted extra monitors can loosen, causing monitors to fall and potentially injure patients, staff, or service technicians.

    Product
    Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0399-2022·2021-12-29

    Cholesterol Reagent Recalled for Calibration Failures and Erroneous Results

    Beckman Coulter is recalling 1,433 units of a cholesterol reagent that may fail calibration and produce erroneous low test results. Affected units were distributed nationwide and internationally.

    Product
    SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0393-2022·2021-12-29

    Stryker DARCO Screw Recall: Incorrect Product in Packaging

    Wright Medical Technology Inc is recalling 250 units of Stryker DARCO Screws (Lot #1643355) because the incorrect product was found in the packaging. Affected units were distributed across multiple U.S. states and countries worldwide.

    Product
    Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0409-2022·2021-12-29

    Malosa Core SMILE Pack Medical Refractive Kit Recalled for Packaging Defect

    Beaver Visitec International is recalling the Malosa Core SMILE Pack 1-Medical Refractive Kit because packaging may contain small holes that compromise sterility. The recall affects 680 units distributed in nine states.

    Product
    Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-0348-2022·2021-12-29

    Twin Brook Creamery Pasteurized Milk Recalled for Inhibitory Substance

    Twin Brook Creamery brand pasteurized 1% milk in 64 oz and 32 oz glass bottles is being recalled because an inhibitory substance was detected. Fishtrap Dairy LLC is asking consumers not to consume the product.

    Product
    Twin Brook Creamery brand, Pasteurized 1% Milk, Vit D3 Vit A Palmitate, 100% Jersey Milk, packaged in 64 oz glass bottle with a green cap, Refrigerated, UPC8 97605 00102 6. Twin Brook Creamery brand, Pasteurized 1% Milk, Vit D3 Vit A Palmitate, 100% Jersey Milk, packaged…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0407-2022·2021-12-29

    Cataract Surgery Kits Recalled for Compromised Sterile Packaging

    Beaver Visitec is recalling Malosa Core Phaco Pack 1 cataract surgery kits (Part Number: MMK833/2) because packaging may have small holes that compromise product sterility. The recall affects 120 units distributed across nine states.

    Product
    Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-0345-2022·2021-12-29

    Cesarina Cookies recalled for undeclared milk allergen

    Cesarina Bakery, Inc. is recalling Cesarina Cookies (Assorted, 16 oz) due to undeclared milk. Consumers with milk allergies face a potential allergic reaction risk.

    Product
    Cesarina Cookies, Assorted Cookies, Net Weight 16oz (453.59g)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0291-2022·2021-12-29

    Rompe Pecho Cough Syrup Recalled for Microbial Contamination

    Efficient Laboratories, Inc. is recalling Rompe Pecho DM cough syrup (6 fl oz bottles) due to microbial contamination of the non-sterile product. The recall affects 27,206 bottles distributed nationwide.

    Product
    ROMPE PECHO — ROMPE PECHO (DEXTROMETHORPHAN HBR, GUAIFENESIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0287-2022·2021-12-29

    Give and Go Two-Bite Cupcakes Recalled for Potential Metal Contamination

    Give and Go is recalling two-bite vanilla and chocolate cupcakes nationwide due to the potential for metal in the product. Consumers should not eat the affected cupcakes and should return them to the place of purchase.

    Product
    two-bite vanilla & chocolate cupcakes 10 oz. UPC 7 70981 03127 9 20 oz. UPC 7 70981 03104 0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0294-2022·2021-12-29

    Two-Bite Chocolate Cupcakes Recalled for Potential Metal Contamination

    GIVE AND GO is recalling two-bite chocolate cupcakes (10 oz, UPC 7 70981 04460 6) distributed nationwide due to the potential presence of metal in the product.

    Product
    two-bite chocolate cupcakes 10 oz. UPC 7 70981 04460 6
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0342-2022·2021-12-29

    Cesarina Cookies Mini Linzer Tart recalled for undeclared milk

    Cesarina Bakery, Inc is recalling Cesarina Cookies Mini Linzer Tart in Apricot Raspberry flavor because the product contains undeclared milk, a common allergen that poses a health risk to consumers with milk allergies.

    Product
    Cesarina Cookies, Mini Linzer Tart, Apricot Raspberry, Net Weight 16oz (453.59g)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0299-2022·2021-12-29

    Red Velvet Cupcakes Recalled for Potential Metal Contamination

    GIVE AND GO is recalling multiple brands of red velvet cupcakes nationwide due to potential metal in the product. Consumers should not eat affected products and should return them to the retailer.

    Product
    two-bite red velvet cupcakes 10 oz. UPC 7 70981 05520 6 Marketside red velvet cupcakes 10 oz. UPC 6 81131 10150 9 11.7 oz. UPC 6 81131 24843 3 NL two-bite Red Velvet Premium Cupcakes 12PK 05620 7.52 lbs. case UPC 1 07 70981 05620 0 Favorite Day Gourmet red velvet filled…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0298-2022·2021-12-29

    NL Vanilla Iced Assorted Cupcakes Recalled Due to Metal Contamination

    GIVE AND GO is recalling NL Vanilla Iced Assorted cupcakes (24-pack, 15 lbs case) nationwide due to potential metal contamination in the product. Consumers should not eat the product.

    Product
    NL Vanilla Iced Assorted cupcakes 24PK 983352 15 lbs. case UPC 1 07 70981 03948 7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0398-2022·2021-12-29

    VirtuTRAX Instrument Navigator devices may not tighten properly

    Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator devices due to a potential mechanical failure that could prevent proper securing of instruments. The device may not tighten onto the instrument as intended.

    Product
    VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0303-2022·2021-12-29

    Two-Bite and Marketside Unicorn Cupcakes Recalled for Metal Contamination

    GIVE AND GO is recalling two-bite and Marketside brand unicorn cupcakes nationwide due to potential metal contamination in the product.

    Product
    two-bite unicorn cupcakes 10 oz. UPC 7 70981 04417 0 Marketside unicorn cupcakes 10 oz. UPC 6 81131 10125 7
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0288-2022·2021-12-29

    Two-Bite Chocolate Cupcakes Recalled for Potential Metal Contamination

    GIVE AND GO is recalling two-bite chocolate cupcakes (10 oz., UPC 7 70981 04470 5) distributed nationwide due to potential metal contamination in the product.

    Product
    two-bite chocolate cupcakes 10 oz. UPC 7 70981 04470 5
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0337-2022·2021-12-29

    Golden Flax Seed Scala Bread Recalled for Undeclared Sesame

    Calise & Sons Bakery is recalling Golden Flax Seed Scala Bread because it contains undeclared sesame seeds, which poses an allergen risk to consumers with sesame allergies.

    Product
    Golden Flax Seed Scala Bread,
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0296-2022·2021-12-29

    Vanilla Cupcakes Recalled for Potential Metal Contamination

    Give and Go is recalling multiple brands of vanilla cupcakes nationwide due to potential metal contamination in the product.

    Product
    two-bite vanilla cupcakes 10 oz. UPC 7 70981 03109 5 284 g UPC 7 70981 73109 4 Bakery Fresh Goodness mini vanilla cupcakes 10 oz. UPC 0 11110 18230 2 NL Vanilla cupcakes 12PK - Everyday 03540 7.52 lbs. case UPC 1 07 70981 03540 3 7 Select vanilla mini cupcakes 10 oz. UPC 0…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-12292021-01·2021-12-29

    USDA Issues Public Health Alert for Ineligible Imported Meat and Poultry from China

    USDA FSIS issued a public health alert for imported meat and poultry from China that were not inspected for import. Consumers are advised not to consume these products.

    Product
    FSIS Issues Public Health Alert for Ineligible Imported Meat and Poultry Products from China
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0289-2022·2021-12-29

    Kimberley's Bakeshoppe vanilla cupcakes recalled for potential metal

    GIVE AND GO is recalling Kimberley's Bakeshoppe vanilla cupcakes (11.2 oz.) nationwide due to the potential for metal in the product.

    Product
    Kimberley's Bakeshoppe vanilla cupcakes 11.2 oz. UPC 7 70981 31213 2
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0406-2022·2021-12-29

    Surgical Corneal Kit Packaging May Compromise Product Sterility

    Beaver Visitec is recalling the Malosa Core Surface Treatment Pack surgical kit because packaging may have holes that compromise sterility during eye procedures.

    Product
    Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-0305-2022·2021-12-29

    Vanilla Cupcakes Recalled Due to Potential Metal Contamination

    GIVE AND GO is recalling Favorite Day and Kimberley's bakeshoppe vanilla-filled cupcakes due to potential metal contamination. Affected products were distributed nationwide.

    Product
    Favorite Day Gourmet Vanilla filled cupcakes 11.7 oz. UPC 0 85239 42018 8 Kimberley's bakeshoppe Vanilla bean filled gourmet cupcakes 11.7 oz. UPC 7 70981 31117 3 Kimberley's bakeshoppe vanilla filled gourmet cupcakes 11.7 oz. UPC 7 70981 31003 9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0313-2022·2021-12-29

    Wondershop Frosted Sugar Cookies Recalled for Potential Metal Contamination

    GIVE AND GO is recalling approximately 1,142,754 units of Wondershop at Target Frosted Sugar Cookies due to potential metal contamination in the product.

    Product
    Wondershop at Target Frosted Sugar Cookies 13.5 oz. UPC 0 85239 13621 8
    Category
    Food
    Distribution
    Distributed nationwide