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.

11126–11150 of 22147

  • HighCPSC·24266·2024-06-13

    Beaumont Plus ST Bicycles with Disc Brakes Recalled for Brake Failure Risk

    Retrospec is recalling about 530 Beaumont Plus ST bicycles with disc brakes because the front brake rotor and pads can become misaligned, potentially causing brake failure and crashes. No injuries have been reported.

    Product
    Beaumont Plus ST Bikes with disc brakes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24261·2024-06-13

    Black Diamond Neve Strap Crampons Recalled Due to Fall Hazard

    Black Diamond Equipment is recalling Neve Strap Crampons and Accessory Kits because screws connecting the heel cup to the crampon can loosen, causing the heel cup to detach and creating a fall hazard. The firm has received three reports of incidents but no injuries have been reported.

    Product
    Neve Strap Crampons and Accessory Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1375-2024·2024-06-12

    Tortilla de Harina Recalled for Undeclared Wheat Allergen

    El Mirasol, Inc. is recalling Tortilla de Harina flour tortillas in Florida due to undeclared wheat allergen. Consumers with wheat allergies should not consume this product.

    Product
    Tortilla de Harina, 400 gr, 10 count, packaged in clear plastic bag, 20 packages per case.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1302-2024·2024-06-12

    Panera Kitchen Sink Cookie Recalled Due to Potential Salmonella Contamination

    Panera Kitchen Sink Cookie dough pucks from Rise Baking Company are being recalled due to potential Salmonella contamination. The recall covers 29,019 cases distributed across 20 U.S. states.

    Product
    Panera Kitchen Sink Cookie, Net Wt. 45 lb (20.41 kg), 120/6 oz dough pucks/case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2014-2024·2024-06-12

    Vascular graft component separation risk prompts medical device recall

    Atrium Medical Corporation recalled FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units are affected worldwide.

    Product
    FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1941-2024·2024-06-12

    Synchro2 Guidewires: PTFE coating damage from improper backloading technique

    Stryker Neurovascular is recalling certain lots of Synchro2 Guidewires due to PTFE coating damage caused by backloading through an introducer accessory with manufacturing variations. Affected users should discontinue the backloading technique.

    Product
    The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewires are compatible with existing microcatheters used in common procedures such as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1956-2024·2024-06-12

    Vascular Graft Slider Component May Separate from Core

    Atrium Medical is recalling ADVANTA VXT vascular grafts worldwide after reports of the slider swivel rod separating from the swivel core with a notable gap between components.

    Product
    ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1962-2024·2024-06-12

    ADVANTA VXT Vascular Graft Slider Rod Separation Recall

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the slider rod from the swivel core, with a gap between components. Approximately 53,308 units are affected globally.

    Product
    ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1942-2024·2024-06-12

    WAVi Research EEG Desktop System recalled due to FDA Warning Letter

    WAVi Co. is recalling 281 units of the WAVi Research EEG Desktop System following an FDA-issued Warning Letter. The company requested the return of components due to closure of their research study.

    Product
    WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporates use of the firm's cleared EEG analysis technology (the WAVi SCAN EEG System a
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Food)·F-1303-2024·2024-06-12

    Rise Baking Company Cowboy Cookie recalled for potential Salmonella contamination

    Rise Baking Company is recalling Cowboy Cookie dough pucks distributed across 20 states due to potential Salmonella contamination. Affected cases are identified by code 4117N1.

    Product
    Rise Baking Company Cowboy Cookie, Net Wt. 18.75 lb (8.5 kg), 300/ 1.0 oz dough pucks/case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1946-2024·2024-06-12

    Newport Laser Systems Recalled for Removable Safety Key Defect

    Newport has recalled Class II laser systems because their key-actuated safety switch can be removed while the laser remains on, violating federal safety requirements.

    Product
    Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2018-2024·2024-06-12

    Vascular graft recalled due to swivel rod separation risk

    Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. The recall affects 53,308 units distributed worldwide.

    Product
    FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2024·2024-06-12

    Hysteroscope recalled due to missed required leakage test

    Olympus OES 4000 Hysteroscope Model A4674A is being recalled because a required leakage test was not performed after device repairs. Liquid could enter the eyepiece, causing a foggy image during use.

    Product
    OES 4000 Hysteroscope, Model/Catalog Number: A4674A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1943-2024·2024-06-12

    Arial Emergency Mobile App Restarts Cause Alert Overload and Call Failures

    The Arial mobile application experiences frequent restarts on iOS 17.4 and 17.5, causing alert overload, communication failures, and offline status in healthcare facilities.

    Product
    Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the Arial Emergency and Nurse Call System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2008-2024·2024-06-12

    FLIXENE vascular graft recalled for slider separation defect

    Atrium Medical recalls FLIXENE vascular grafts due to reported separation between the slider rod and swivel core. Affected grafts may fail to function properly if deployed.

    Product
    FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1961-2024·2024-06-12

    Vascular Graft Recalled Due to Slider Component Separation Risk

    Atrium Medical's ADVANTA VXT vascular grafts are recalled due to reported separation of the slider component from the swivel core. Over 53,000 units worldwide may be affected.

    Product
    ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1992-2024·2024-06-12

    Vascular Graft Recalled Due to Swivel Rod Separation Risk

    Atrium Medical is recalling ADVANTA VXT vascular grafts worldwide due to complaints of the swivel rod separating from the core, which could compromise device function during medical procedures.

    Product
    ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2024·2024-06-12

    Vascular Graft Recall Due to Swivel Rod Separation

    Atrium Medical is recalling the ADVANTA VXT vascular graft due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This component separation could affect device function.

    Product
    ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1295-2024·2024-06-12

    Happy Farms Cream Cheese Spreads Recalled for Potential Salmonella

    Happy Farms cream cheese spreads sold at Aldi were recalled due to potential Salmonella contamination affecting 835,721 units distributed across 19 states and Puerto Rico.

    Product
    Variety Tray Chive Onion (UPC 4099100 101751), Strawberry (UPC 4099100 101744), and Plain Cream Cheese Spread (UPC 4099100 101737), each container Net Wt. 8 oz. (226g). Keep Refrigerated, packaged under the brand Happy Farms, UPC . Dist & Sold Exclusively by Aldi, Batavia, IL
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1938-2024·2024-06-12

    Medline Luer Slip Syringes Recalled for Inaccurate Volume Delivery

    Medline Industries is recalling over 5 million Luer Slip disposable syringes because testing documentation does not confirm they deliver accurate volumes across their claimed capacity range. This poses a risk to patient health.

    Product
    MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2010-2024·2024-06-12

    Vascular Graft Device Recalled for Slider Rod Separation Risk

    Atrium Medical Corporation is recalling approximately 53,308 FLIXENE vascular graft units worldwide due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating gaps that could affect device performance.

    Product
    FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1976-2024·2024-06-12

    Vascular graft device recalled for swivel component separation

    Atrium Medical recalls ADVANTA VXT vascular grafts due to reports of the Slider GDS Swivel Rod separating from the Swivel Core. The internal component separation could compromise device function.

    Product
    ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1959-2024·2024-06-12

    ADVANTA VXT Vascular Graft Recalled for Slider Rod Separation

    The ADVANTA VXT vascular graft is being recalled because its slider rod can separate from the swivel core, creating a gap between components. No injuries have been reported.

    Product
    ADVANTA VXT, 6X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1980-2024·2024-06-12

    Vascular Graft Recall for Component Separation in ADVANTA VXT

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This component separation could compromise device function.

    Product
    ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2016-2024·2024-06-12

    FLIXENE Vascular Graft Recalled for Slider Component Separation

    Atrium Medical is recalling the FLIXENE vascular graft due to reported separation of the Slider GDS Swivel Rod from its core. Component separation could affect graft function.

    Product
    FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide