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.

18401–18425 of 50407

  • HighFDA (Devices)·Z-0415-2022·2021-12-29

    Surgical Suction Instruments Recalled for Calibration Defect Risk

    Acclarent's TruDi NAV Suction Instruments may be incorrectly calibrated, affecting surgical navigation accuracy. If undetected, the error could cause tissue damage, arterial injury, or nerve damage.

    Product
    TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
    Category
    Medical Device
    Distribution
    39 states
  • HighNHTSA·21V00N000·2021-12-29

    Kenworth and Peterbilt Commercial Trucks Recalled for Methane Detection System Failure

    PACCAR is recalling approximately 1,107 Kenworth and Peterbilt commercial trucks (2016–2022) due to methane detection system power loss. If the system loses electrical power, operators may not detect dangerous methane levels, increasing fire and injury risk.

    Product
    KENWORTH — KENWORTH, PETERBILT T680, T880, 567, 536
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0414-2022·2021-12-29

    Skinny Needle with Chiba Tip recalled for debris contamination

    Cook Inc. is recalling Skinny Needles with Chiba Tip due to black debris on internal components that may cause local inflammatory reactions if the product is used.

    Product
    Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0310-2022·2021-12-29

    Freshness Guaranteed Cookies N' Creme Tiny Pies Recalled for Metal Contamination

    Freshness Guaranteed Cookies N' Creme Tiny Pies (12.7 oz., UPC 0 78742 37636 3) are being recalled nationwide due to potential metal contamination in the product.

    Product
    Freshness Guaranteed Cookies N' Creme Tiny Pies 12.7 oz. UPC 0 78742 37636 3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0304-2022·2021-12-29

    Give and Go Kids Cupcakes Recalled for Potential Metal Contamination

    Give and Go Prepared Foods Corp. is recalling Kids Cupcakes chocolate and vanilla in 21.9 oz. packages nationwide due to potential metal contamination in the product.

    Product
    Give and Go Prepared Foods Corp. Kids Cupcakes chocolate & vanilla kids cupcakes 21.9 oz. UPC 7 70981 31091 6
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0306-2022·2021-12-29

    Triple Chocolate Gourmet Cupcakes Recalled for Potential Metal Contamination

    Kimberley's bakeshoppe and Favorite Day brand triple chocolate filled gourmet cupcakes are being recalled nationwide due to potential metal in the product. Consumers should not eat the affected products.

    Product
    Kimberley's bakeshoppe triple chocolate filled gourmet cupcakes 11.7 oz. UPC 7 70981 31001 5 and 7 70981 31116 6 Favorite Day Gourmet Triple Chocolate filled cupcakes 11.7 oz. UPC 0 85239 42017 1
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0292-2022·2021-12-29

    Kimberley's Bakeshoppe Christmas Cupcakes Recalled for Potential Metal Contamination

    GIVE AND GO is recalling Kimberley's Bakeshoppe Christmas cupcakes with rings (22 oz.) due to potential metal in the product. The recall affects approximately 1.14 million units distributed nationwide.

    Product
    Kimberley's bakeshoppe Christmas cupcakes with rings 22 oz. UPC 7 70981 31188 3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0410-2022·2021-12-29

    Medical Refractive Surgery Kit Recalled for Sterility-Compromising Packaging Defects

    Beaver Visitec is recalling 1,170 units of its Malosa Core SMILE Pack 2 surgical refractive kit because packaging may contain small holes that could compromise sterility. Affected units were distributed across nine states.

    Product
    Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK967
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-0349-2022·2021-12-29

    Twin Brook Creamery Chocolate Milk Recall Due to Inhibitory Substance

    Fishtrap Dairy LLC is recalling Twin Brook Creamery brand Pasteurized Chocolate Milk in 16 oz., 32 oz., and 64 oz. glass bottles due to detection of an inhibitory substance. Affected products have the best-by date of 12/05/21 and Plant #53-05.

    Product
    Twin Brook Creamery brand, Pasteurized Chocolate Milk, > 3.25 % fat, packaged in 16 oz. glass bottle with a brown cap, Refrigerated. UPC 8 97605 00117 0. Twin Brook Creamery brand, Pasteurized Chocolate Milk, > 3.25 % fat, packaged in 32 oz. glass bottle with a brown cap…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0347-2022·2021-12-29

    Cesarina Cookies recalled due to undeclared milk

    Cesarina Bakery, Inc. is recalling Cesarina Cookies, Raspberry Sandwich Chocolate Dipped (16oz) due to undeclared milk. The product may contain milk not stated on the label, posing a risk to consumers with milk allergies.

    Product
    Cesarina Cookies, Raspberry Sandwich Chocolate Dipped, Net Weight 16oz (453.59g)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0395-2022·2021-12-29

    VirtuTRAX Instrument Navigator Sensor May Fail to Tighten

    Civco Medical recalls VirtuTRAX Instrument Navigator sensors that may fail to tighten onto instruments during use. No injuries reported.

    Product
    VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V00K000·2021-12-28

    2022 Hyundai Santa Fe instrument cluster display may invert upon startup

    Hyundai is recalling certain 2022 Santa Fe PHEV and HEV vehicles because the instrument cluster display may invert upon startup, making it illegible and preventing drivers from seeing speed and safety warnings.

    Product
    HYUNDAI — HYUNDAI SANTA FE PLUG-IN HYBRID, SANTA FE HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V00J000·2021-12-27

    Mercedes-Benz Recalls 2022 EQS and S-Class for eCall Software Defect

    Mercedes-Benz is recalling 2022 EQS 450, S 500, and S 580 vehicles because a software defect may disable the emergency call system, potentially delaying emergency response.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ EQS 450, S 500 4MATIC, S 580 4MATIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21E103000·2021-12-23

    Toyota power steering gear assembly recalled for oil leak risk

    Toyota is recalling power steering gear assemblies for certain Tundra and Sequoia models from 2007-2022. The components may be incorrectly manufactured, causing oil leaks that could result in sudden loss of power steering assist and increased crash risk.

    Product
    TOYOTA — TOYOTA TUNDRA, SEQUOIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V00H000·2021-12-23

    Freightliner Custom Chassis recreational vehicles electrical lighting system failure

    Daimler Trucks North America is recalling Freightliner Custom Chassis recreational vehicles with defective power distribution modules that may disable brake lights, turn signals, and rear marker lights, reducing visibility and increasing crash risk.

    Product
    FCCC — FCCC XCR, XCP, XCM, XCS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2022·2021-12-22

    Cardinal Health Recalls RoyalSilk Surgical Gowns for Compromised Packaging Seals

    Cardinal Health is recalling 364,481 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential for open packaging seals that could compromise sterility. The recalled units were distributed worldwide.

    Product
    RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0328-2022·2021-12-22

    Kool-Aid Ice Blue Raspberry Lemonade Drink Mix Recalled for Glass and Metal

    Kraft Heinz Foods Company is recalling Kool-Aid ice blue raspberry lemonade drink mix powder (20 oz.) due to potential glass and metal contamination in the product.

    Product
    Kool-Aid ice blue raspberry lemonade drink mix powder 20 oz. UPC 043000954072
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2022·2021-12-22

    Orthopedic Femur Plate Recalled for Incorrect MRI Safety Information

    Smith & Nephew is recalling 35 units of EVOS Condylar Medial Distal Femur Plate due to incorrect MRI scanning safety information in the product instructions. The instructions contained erroneous data that could affect patient safety during MRI procedures.

    Product
    smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2022·2021-12-22

    Medline Venous Access Pack-LF Recalled for Expired Saline Component

    Medline is recalling Venous Access Pack-LF Convenience Kits because the included saline solution component expired before the kit's labeled expiration date, creating a quality and safety issue.

    Product
    Venous Access Pack-LF Convenience Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0330-2022·2021-12-22

    Kool-Aid Tropical Punch Drink Mix Recalled for Glass and Metal Contamination

    Kraft Heinz Foods is recalling Kool-Aid Tropical Punch "on the go" 10-pack drink mix powder due to potential contamination with glass and metal fragments. The affected product was distributed nationwide and internationally.

    Product
    Kool-Aid Tropical Punch "on the go" 10 pack net wt. 6.6 oz. drink mix powder UPC 043000023464
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2022·2021-12-22

    Surgical gowns recalled due to potential compromised sterility from packaging seals

    Cardinal Health is recalling 363,480 units of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns due to potential open packaging seals that could compromise product sterility.

    Product
    SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2022·2021-12-22

    Boston Scientific ROTAPRO System Console Recalled for Manufacturing Instruction Deficiency

    Boston Scientific recalled 7 ROTAPRO rotational atherectomy system consoles due to incomplete manufacturing instructions regarding proper handling of the pneumatic kit component upon failure. Affected devices were distributed in six US states and Germany.

    Product
    Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0325-2022·2021-12-22

    Country Time Half Lemonade and Half Iced Tea Drink Mix Recalled for Glass and Metal

    Kraft Heinz Foods Company is recalling Country Time Half lemonade and Half iced tea drink mix powder due to potential glass and metal fragments in the product.

    Product
    Country Time Half lemonade and Half iced tea drink mix powder 19 oz. UPC 043000046005 82.5 oz. UPC 043000046012
    Category
    Food
    Distribution
    Distributed nationwide