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.

20901–20925 of 50413

  • HighFDA (Devices)·Z-1145-2021·2021-03-03

    Smiths Medical Recalls Bivona Cuffless FlexTend Tracheostomy Tubes Due to Packaging Error

    Smiths Medical is recalling specific lots of Bivona Cuffless FlexTend Tracheostomy Tubes because they may have been packaged with the wrong neck flange, posing a risk of patient injury.

    Product
    Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway access for a tracheotomized patient for up to 29 days. It…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1142-2021·2021-03-03

    Recall of Parietex Hydrophilic Anatomical Mesh Due to Incorrect Side Labeling

    Covidien is recalling Parietex hydrophilic anatomical mesh where the package label indicates left-side use but contains a right-side device. This labeling error can lead to implant failure and hernia recurrence.

    Product
    Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or posterior open procedures Item Code: TECT1510AL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V132000·2021-03-03

    2021 Volkswagen Atlas Wheels May Separate Due to Machining Defect

    Volkswagen is recalling certain 2021 Atlas and Atlas Cross Sport vehicles due to improperly machined wheel lug bolt holes that may prevent wheels from attaching properly, risking wheel separation and crashes.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS, ATLAS CROSS SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2021·2021-03-03

    Northgate Recalls Steris CO2MPACT Endoscopic Insufflator Systems Due to Tubing Material Error

    Northgate Technologies is recalling 45 Steris CO2MPACT Endoscopic Insufflator systems because an internal tubing component was made with incorrect, untested material.

    Product
    Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1141-2021·2021-03-03

    Ecolab Recalls Slush and Warmer Disc Drapes Due to Sterile Barrier Risk

    Ecolab is recalling specific lots of ORS-320 Slush + Warmer Disc Drapes because manufacturing slits may breach the sterile barrier, posing an infection risk to patients.

    Product
    Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V118000·2021-02-25

    Jaguar Recalls 2019-2020 F-Pace for High Beam Indicator Software Defect

    Jaguar is recalling 2019-2020 F-Pace vehicles because the Auto High Beam system fails to display an indicator when high beams activate, potentially reducing visibility for oncoming traffic.

    Product
    JAGUAR — JAGUAR F-PACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21089·2021-02-25

    Dr. Reddy's Recalls Prescription Blister Packages Due to Poisoning Risk

    Dr. Reddy's is recalling prescription blister packages because the packaging is not child-resistant, posing a poisoning risk to young children.

    Product
    Imatinib Mesylate Tablets 100 mg, Imatinib Mesylate Tablets 400 mg, Pregabalin Capsules 50 mg, Pregabalin Capsules 75 mg, Pregabalin Capsules 100 mg, Pregabalin Capsules 150 mg, Sevelamer Carbonate Tablets 800 mg, Tadalafil Tablets 5 mg and Tadalafil Tablets 20 mg
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-02252021-01·2021-02-25

    Whole Foods Beef Meatballs Recalled for Undeclared Milk Allergen

    Whole Foods Market issued a public health alert for beef meatballs with marinara sauce containing undeclared parmesan cheese. Consumers with milk allergies should not consume the product.

    Product
    FSIS Issues Public Health Alert for Beef Meatball Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    9 states
  • HighCPSC·21722·2021-02-25

    Home Depot Recalls Wood Windsor Dining Chair Sets Due to Fall Hazard

    Home Depot is recalling StyleWell Wood Windsor Dining Chair Sets because the back can detach, posing a fall hazard. No injuries have been reported.

    Product
    StyleWell Wood Windsor Dining Chair Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V117000·2021-02-25

    Land Rover Recalls 2018-2020 Models for High Beam Indicator Defect

    Jaguar Land Rover is recalling 2018-2020 Range Rover and Discovery models because the high beam indicator may not display, increasing crash risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER, RANGE ROVER SPORT, RANGE ROVER VELAR, DISCOVERY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V116000·2021-02-25

    Black Series Campers Recalls Trailers Due to Electrical Fire Risk

    Black Series Campers is recalling 2020-2021 trailers equipped with specific Curt emergency breakaway kits because a depleted battery can overload the electrical system, increasing the risk of a fire.

    Product
    BLACK SERIES CAMPERS — BLACK SERIES CAMPERS HQ21, HQ22T, HQ15, C12
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21723·2021-02-25

    deSensua Essential Oils Recalled for Non-Child-Resistant Packaging and Poisoning Risk

    MTIG Productions is recalling deSensua Wintergreen, Birch, and Pain Soother Essential Oils because the packaging is not child-resistant, posing a risk of poisoning if swallowed by young children.

    Product
    deSensua Wintergreen, Birch and Pain Soother Essential Oils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0299-2021·2021-02-24

    Barron County Organics Recalls Unpasteurized Frozen Custard

    Barron County Organics is recalling 20 Mile Peach Cream Organic Frozen Custard because ingredients were not pasteurized after blending as required by Wisconsin state regulations.

    Product
    20 Mile Peach Cream, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1122-2021·2021-02-24

    Baxter Gambro Hemodialysis Blood Set Recalled for Kinked Access Lines

    Baxter Healthcare is recalling Gambro Cartridge Low Volume Blood Transport Systems for hemodialysis due to reports of kinked access lines during treatment.

    Product
    Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0303-2021·2021-02-24

    Barron County Organics Recalls Frozen Custard Due to Pasteurization Failure

    Barron County Organics is recalling Salted Caramel with Cashew Praline Organic Frozen Custard because ingredients were not pasteurized after blending as required by Wisconsin state regulations.

    Product
    20 Mile Salted Caramel with Cashew Praline, Organic Frozen Custard, Contents: One U.S. Pint and 86 oz. Scoopers. UPC 50005-48800. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813.
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·21V112000·2021-02-24

    2021 International LT Trucks Recalled for Potential Flywheel Detachment

    Certain 2021 International LT vehicles with Cummins X15 engines may have improperly torqued flywheel capscrews that could detach during operation, causing loss of drive power and risk of ejected engine parts.

    Product
    INTERNATIONAL — INTERNATIONAL LT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1109-2021·2021-02-24

    BD 10 ml Syringes Recalled for Potential Open Seals and Sterility Compromise

    Becton Dickinson is recalling 155,200 10 ml syringes because open packaging seals may compromise sterility. The product was distributed in the US and Canada.

    Product
    BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1119-2021·2021-02-24

    Baxter Gambro Cartridge Single Needle Conversion Kit Recalled for Kinked Lines

    Baxter Healthcare is recalling Gambro Cartridge Single Needle Conversion Kits due to reports of kinked access lines during hemodialysis treatments.

    Product
    Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states