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.

22401–22425 of 50429

  • HighFDA (Food)·F-1334-2020·2020-08-19

    San Francisco Street Bakery Sourdough Rye Bread Recalled for Undeclared Soy

    San Francisco Street Bakery Inc. is recalling Sourdough Rye Bread because the product was treated with pan release spray containing soy lecithin, which is not declared on the label.

    Product
    Sourdough Rye Bread, San Francisco Street Bakery brand, keep at ambient temperature. Sold as an individual unit through on-site retail store bulk display, net weight unknown. No UPC.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2770-2020·2020-08-19

    Ortho VITROS Anti-SARS-CoV-2 Reagent Recalled for Potential False Negatives

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total Reagent because swapped bottles may cause false negative or delayed results.

    Product
    VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2799-2020·2020-08-19

    United Imaging Recalls uEXPLORER PET/CT System for Potential Sharp Edges

    Shanghai United Imaging Healthcare is recalling one uEXPLORER PET/CT Diagnostic Imaging System in Texas due to potential sharp edges and image data issues.

    Product
    uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2800-2020·2020-08-19

    United Imaging Recalls uMI 550 PET/CT Systems Due to Imaging and Safety Defects

    Shanghai United Imaging Healthcare is recalling four uMI 550 PET/CT systems due to defects that may cause image artifacts, scanning interruptions, or sharp edges.

    Product
    uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V492000·2020-08-19

    Spartan Fire Gladiator Recalled for Excessively Bright Exterior Lights

    Spartan Fire is recalling one 2018 Gladiator vehicle because its exterior LED lights may be too bright, potentially blinding other drivers and increasing crash risk.

    Product
    SPARTAN FIRE — SPARTAN FIRE GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2785-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage

    Flower Orthopedics is recalling 25 calcaneus plates because the contract manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2771-2020·2020-08-19

    Ortho Clinical Diagnostics Recalls VITROS Anti-SARS-CoV-2 IgG Reagent Packs

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Reagent Packs because swapped reagent bottles may cause false negative or delayed results.

    Product
    VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1329-2020·2020-08-19

    San Francisco Street Bakery Recalls French Bread for Undeclared Soy

    San Francisco Street Bakery Inc. is recalling 10 loaves of French Bread sold in Washington because the product contains soy lecithin, which is not declared on the label.

    Product
    French Bread, San Francisco Street Bakery brand, keep at ambient temperature. French Bread sold as an individual unit through the firm's on-site retail store, net weight unknown. No UPC.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2776-2020·2020-08-19

    Luminex Verigene Processor SP Recalled for Potential False Negative Results

    Luminex is recalling Verigene Processor SP systems because an instrument failure may cause false negative results in blood culture tests.

    Product
    Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1155-2020·2020-08-19

    Marketside Peanut Butter Brownies Recalled for Missing Allergen Labeling

    James Skinner Baking Co. is recalling Marketside Peanut Butter Brownies because units may lack the ingredient list, failing to declare major allergens including peanuts, wheat, milk, egg, and soy.

    Product
    Marketside Peanut Butter Brownie, Net Wt. 19 oz, Distributed by Walmart Inc. Bentonville, AR
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2793-2020·2020-08-19

    Brainlab Kick Navigation Station Recalled for Incorrect Calibration

    Brainlab AG is recalling 9 Kick navigation stations due to incorrect manufacturer calibration. The units were distributed in the US and internationally.

    Product
    BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1331-2020·2020-08-19

    San Francisco Street Bakery Recalls Olive Levain Bread for Undeclared Soy

    San Francisco Street Bakery is recalling Olive Levain Bread because it contains soy lecithin, an ingredient not listed on the label.

    Product
    Olive Levain Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, net weight 16 oz (454 g). UPC 0 088613 10014 8. The product label is read in parts: "***Olive Levain Bread ***Ingredients: unbleached bread flour…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1153-2020·2020-08-19

    Sweeteeth Chocolate Bar Recalled for Unlabeled Soy Allergen

    Sweeteeth Chocolate LLC is recalling White Chocolate & Ginger Snaps bars because they contain soy, which is not listed on the label.

    Product
    Sweeteeth O-Snap! (White Chocolate & Ginger Snaps) Chocolate Bar, NET WT. 3 OZ. (85.05G), Manufactured by: Sweeteeth Chocolate LLC. 1204 McNew St. Hanahan, SC 29410 www.evopizza.com, Best By: 07/28/2021, UPC 7 36211 11895 0
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·20V487000·2020-08-18

    KME Fire Trucks Recalled for Excessively Bright LED Lights

    KME is recalling 38 fire trucks because certain LED lights are too bright, potentially blinding other drivers and increasing crash risk.

    Product
    KME — KME PREDATOR SS RESCUE, PREDATOR PANTHER AERIAL, COMMERCIAL PUMPER, PREDATOR SS AERIAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V488000·2020-08-18

    Forest River Recalls Motorhomes With Potential Rear Light Malfunctions

    Forest River is recalling specific 2017-2020 motorhomes because a damaged Power Distribution Module may cause rear marker, brake, or turn signal lights to stop working.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN BERKSHIRE, CROSS COUNTRY, SPORTSCOACH, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E055000·2020-08-18

    Watson & Chalin Recalls SL2065 Lift Axle Suspension Systems

    Watson & Chalin is recalling SL2065 steerable lift axle suspension systems because short pivot cap screws may separate, creating road hazards and increasing crash risk.

    Product
    SUSPENSION:MULTIPLE AXLE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V489000·2020-08-18

    GM Recalls 2020 Chevrolet Corvette for Unlatched Front Trunk Lid Risk

    General Motors is recalling 2020 Chevrolet Corvette vehicles because the front trunk lid can be driven while unlatched, potentially opening at speed and obstructing the driver's view.

    Product
    CHEVROLET — CHEVROLET CORVETTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V477000·2020-08-14

    Motorhome Recall: Defective Wiring Harness May Affect Side Air Bag Deployment

    Forest River is recalling certain 2020-2021 motorhomes with swivel seats due to incorrectly routed wiring harnesses that could damage the side air bag system, risking inadvertent or failed deployment in a crash.

    Product
    COACHMEN — COACHMEN, FOREST RIVER, DYNAMAX GALLERIA, PRISM, FORESTER, SUNSEEKER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V483000·2020-08-14

    2021 BMW X5 and X6 Vehicles Recalled for Defective Tires

    BMW is recalling 2021 X5 and X6 models equipped with certain Pirelli tires. The tires may have damaged inner layers that can cause rapid pressure loss while driving, affecting vehicle control.

    Product
    BMW — BMW X5, X6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V485000·2020-08-14

    Freightliner Custom Chassis Trucks Recalled for Instrument Panel Glare

    Daimler Trucks North America is recalling certain 2015-2019 Freightliner Custom Chassis trucks because the instrument panel brightness cannot be adjusted, potentially causing glare at night.

    Product
    FCCC — FCCC XCM, XCS, XCL, XCR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V475000·2020-08-13

    Chrysler Recalls Ram 1500 and Jeep Grand Cherokee for Engine Stall Risk

    Chrysler is recalling 2014-2018 Ram 1500 and 2014-2016 Jeep Grand Cherokee diesel vehicles because a sensor defect may cause the engine to stall, increasing crash risk.

    Product
    RAM — RAM, JEEP 1500, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide