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.

8526–8550 of 52968

  • HighFDA (Devices)·Z-1971-2024·2024-06-12

    ADVANTA VXT Vascular Grafts Recalled for Slider Rod Separation

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

    Product
    ADVANTA VXT, 6X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1934-2024·2024-06-12

    LOSPA Tibial Insert Knee Implant Component Recalled for Unsupported Expiration Date

    CORENTEC is recalling LOSPA Tibial Insert knee implant components due to an unsupported 10-year expiration date. Patients with these devices should consult their physician.

    Product
    LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2024·2024-06-12

    Vascular Graft Component Separation Recall: ADVANTA VXT Slider

    Atrium Medical recalls ADVANTA VXT vascular grafts due to separation of the slider swivel rod from its core. The defect affects 53,308 units distributed worldwide.

    Product
    ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    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-1968-2024·2024-06-12

    Vascular graft slider component may separate from core

    Atrium Medical's ADVANTA VXT vascular graft may experience separation of the slider mechanism from its core, affecting over 11,000 US units. No injuries have been reported.

    Product
    ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1987-2024·2024-06-12

    Advanta VXT vascular grafts recalled for swivel rod separation

    Atrium Medical Corporation is recalling the Advanta VXT vascular graft due to reports of the swivel rod separating from the swivel core. The recall affects approximately 53,308 units distributed in the United States and worldwide.

    Product
    ADVANTA VXT, 7X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1998-2024·2024-06-12

    Vascular graft recall due to slider mechanism separation defect

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to separation of the slider mechanism. The defect affects over 53,000 units distributed worldwide and could compromise graft function.

    Product
    ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-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 (Devices)·Z-2013-2024·2024-06-12

    FDA Recalls FLIXENE Vascular Graft Devices for Component Separation

    Atrium Medical Corporation recalls FLIXENE vascular graft devices due to reported separation of the Slider GDS Swivel Rod from its core, which could affect device function.

    Product
    FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2024·2024-06-12

    FDA Recalls ADVANTA VXT Vascular Grafts Due to Component Separation

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts because the Slider GDS Swivel Rod may separate from the Swivel Core. A total of 53,308 units are affected.

    Product
    ADVANTA VXT, 5-8X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0534-2024·2024-06-12

    Prescription migraine drug recalled for manufacturing impurity above FDA limit

    Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate tablets for exceeding FDA acceptable limits of N-Nitroso Desmethyl Rizatriptan impurity. The recall affects 2,400 cartons distributed nationwide.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
    21 states
  • 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
    1 state
  • HighFDA (Devices)·Z-1975-2024·2024-06-12

    ADVANTA VXT vascular graft recalled for swivel rod separation

    Atrium Medical recalls ADVANTA VXT vascular grafts due to reports of swivel rod separation from the swivel core. Affected units distributed worldwide; healthcare providers should evaluate appropriate management.

    Product
    ADVANTA VXT, 6X50, 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
  • HighFDA (Devices)·Z-1995-2024·2024-06-12

    Vascular Graft Component Separation Recall - Atrium Medical ADVANTA VXT

    Atrium Medical Corporation is recalling the ADVANTA VXT vascular graft due to reported separation of the Swivel Rod from the Swivel Core. The component separation poses a risk of device failure.

    Product
    ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-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-1972-2024·2024-06-12

    Vascular Graft Component Separation Risk in ADVANTA VXT Models

    Atrium Medical Corporation recalled 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Patients should consult their healthcare provider regarding appropriate follow-up care.

    Product
    ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2005-2024·2024-06-12

    FLIXENE Vascular Graft Recalled for Slider Swivel Rod Separation

    Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reports of the slider swivel rod separating from the swivel core. The separation could affect device function during vascular procedures.

    Product
    FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1939-2024·2024-06-12

    Stryker Synchro Neuro Guidewires Recalled for PTFE Coating Damage Risk

    Stryker Neurovascular is recalling certain lots of Synchro Neuro Guidewires due to PTFE coating damage that can occur when using a backloading technique with the optional introducer. Clinicians should avoid the backloading technique with affected product.

    Product
    The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 0.014in. The guidewires are compatible with existing microcatheters used in common
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2024·2024-06-12

    ADVANTA VXT vascular graft recalled for slider rod separation

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to complaints of separation between the slider rod and swivel core, which could affect proper device function.

    Product
    ADVANTA VXT, 5X50, 1GDS, NH, STR-SW. Single-Ended Slider. 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 (Drugs)·D-0532-2024·2024-06-12

    Prescription Rizatriptan Benzoate Tablets Recalled for Chemical Impurity

    Glenmark Pharmaceuticals recalls Rizatriptan Benzoate 5mg tablets due to excess N-Nitroso Desmethyl Rizatriptan impurity. The nationwide recall affects 3,480 cartons with lots 19233788 and 19224445.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1285-2024·2024-06-12

    Cola Flavoring Base Product Recalled for Undeclared Sulfites

    Charles Boggini Company is recalling Cola Flavoring Base due to undeclared sulfites. The product may trigger allergic reactions in sulfite-sensitive individuals.

    Product
    Charles Boggini Company Cola Flavoring Base; packaged in 1 gallon jugs and 5 gallon pails
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2004-2024·2024-06-12

    Vascular graft recalled for separation of slider mechanism

    Atrium Medical Corporation recalls FLIXENE vascular grafts due to separation of the slider swivel rod from the core assembly. The device defect affects 53,308 units distributed worldwide.

    Product
    FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide