The Recall Desk

Archive

June 2024 recalls

526 recalls were announced in June 2024.

What the numbers show

Critical
17
Severe
130
High
341
Moderate
34
Low
4

Of the 526 recalls this month scored against our rubric, 3% are Critical, 25% are Severe.

Which agencies issued them

301–400 of 526

  • HighFDA (Food)·F-1300-2024·2024-06-12

    Frozen cookie dough products recalled for potential salmonella contamination

    Rise Baking Company is recalling frozen cookie dough products sold under Costco, Member's Mark, Panera, and Rise Baking brands due to potential Salmonella contamination. The recall affects 29,019 cases distributed across 21 states.

    Product
    Costco Chocolate Chunk Frozen Cookie Dough, Net Wt. 33lb (14.97kg), 1.6 oz dough pucks Member's Mark Chocolate Chunk, Net Wt. 14.85lb (6.74kg), 144/1.65 oz dough pucks/case Panera Chocolate Chipper Cookie, Net Wt. 41.25 lb (18.71kg), 220/3 oz dough pucks/case Rise Baking Jumbo C
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-1282-2024·2024-06-12

    Once Upon a Farm Frozen Meal Recalled for Potential Listeria Contamination

    Once Upon a Farm Organic Plant-Rich Meal (Curried Carrots & Beans) is being recalled due to potential Listeria monocytogenes contamination. The frozen meal is distributed across nine states and has a best-by date of 4/17/2025.

    Product
    Once Upon a Farm Organic Plant-Rich Meal, Curried Carrots & Beans, 3.5 oz, packed in single serving flexible pouches. Product is distributed frozen and is Not-Ready-To-Eat. The end user must cook the product. Cooking instructions are provided for both microwave and stovetop on pa
    Category
    Food
    Distribution
    10 states
  • HighUSDA FSIS·PHA-06122024-01·2024-06-12

    USDA Issues Public Health Alert for Farmstead Bacon Due to Sodium Nitrite Levels

    USDA FSIS issued a public health alert for specific Farmstead Butcher Block pork and beef bacon products because sodium nitrite levels exceeded regulatory limits. No illnesses have been reported.

    Product
    Farmstead Butcher Block LLC — FSIS Issues Public Health Alert For Not-Ready-To-Eat Pork And Beef Bacon Products Due to Sodium Nitrite Levels in Excess of Regulatory Limit
    Category
    Food
    Distribution
    1 state
  • 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 (Food)·F-1301-2024·2024-06-12

    Panera Oatmeal Raisin with Berries Cookies Recalled for Potential Salmonella

    Rise Baking Company is recalling approximately 29,019 cases of Panera Oatmeal Raisin with Berries Cookie dough pucks due to potential Salmonella contamination. The affected products were distributed across 20 states.

    Product
    Panera Oatmeal Raisin with Berries Cookie, Net Wt. 41.25 lb (18.71kg), 220/3 oz cookie dough pucks/case
    Category
    Food
    Distribution
    21 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
    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 (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
    20 states
  • 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 (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 (Devices)·Z-1989-2024·2024-06-12

    ADVANTA VXT Vascular Graft Recalled for Swivel Rod Separation Risk

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts after reports of separation between the Slider GDS Swivel Rod and Swivel Core. This structural defect could affect device performance.

    Product
    ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-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-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-2012-2024·2024-06-12

    Vascular Graft Swivel Component Separation Recall Affects Thousands Nationwide

    FDA recalls FLIXENE vascular grafts after complaints that the swivel rod separates from the swivel core. The defect affects over 53,000 units distributed worldwide.

    Product
    FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1978-2024·2024-06-12

    ADVANTA VXT Vascular Graft Recalled for Component Separation

    ADVANTA VXT vascular grafts are recalled due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating a gap between components.

    Product
    ADVANTA VXT, 7X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2009-2024·2024-06-12

    Vascular graft recalled for swivel rod separation risk

    FDA recalls Atrium Medical's FLIXENE vascular grafts due to reports of the swivel rod separating from the core, potentially compromising device integrity.

    Product
    FLIXENE, 6X50, 1GDS, STR. 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-2017-2024·2024-06-12

    Vascular graft device recalled due to swivel rod separation

    Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation of the swivel rod from the core component. This defect could compromise device function.

    Product
    FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
    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-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-2027-2024·2024-06-12

    GE HealthCare CRITIKON ONE-CUF blood pressure cuffs may give inaccurate readings

    GE HealthCare CRITIKON ONE-CUF blood pressure cuffs may provide inaccurate measurements. The FDA recalls approximately 23,180 boxes distributed across 20 US states.

    Product
    GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX; 2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 17 - 25 CM, 20/BOX; 3. ONE-A2-1B, ONE-CUF, ADULT, 1 TB BAYONET, 23 - 33 CM, 20/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1970-2024·2024-06-12

    Vascular graft recalled for slider rod component separation

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

    Product
    ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2006-2024·2024-06-12

    Vascular graft component separation reported in FLIXENE Slider GDS devices

    Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation between the Slider GDS Swivel Rod and Swivel Core, affecting 53,308 units distributed worldwide.

    Product
    FLIXENE, 7X80, 1GDS, GW. 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-1979-2024·2024-06-12

    ADVANTA VXT Vascular Graft Slider Component Separation Recall

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the slider rod from its core component. This mechanical failure could compromise device functionality.

    Product
    ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2024·2024-06-12

    FLIXENE Vascular Graft Recall Due to Swivel Rod Component Separation

    Atrium Medical recalls FLIXENE vascular grafts due to complaints of the Slider GDS Swivel Rod separating from the Swivel Core. Component separation in implanted vascular grafts could compromise device function.

    Product
    FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1958-2024·2024-06-12

    Vascular graft slider component separation poses implant failure risk

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to separation of the slider swivel rod from its core. This structural defect could lead to device failure. Over 53,000 units are affected worldwide.

    Product
    ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2015-2024·2024-06-12

    FLIXENE Vascular Graft Slider Rod Separation Defect Recall

    Atrium Medical Corporation has recalled FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core and a notable gap between the pieces.

    Product
    FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
    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-1981-2024·2024-06-12

    Vascular graft recalled for reported swivel rod separation from core

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reports of the swivel rod separating from the swivel core. Patients and healthcare providers should contact the manufacturer for guidance.

    Product
    ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2024·2024-06-12

    ADVANTA VXT vascular graft slider component separation recall

    ADVANTA VXT vascular grafts may experience separation of the slider component from its core. This Class II recall affects 53,308 units distributed worldwide.

    Product
    ADVANTA VXT, 8X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2022-2024·2024-06-12

    GlideScope Core 15-inch Monitor Software Issue Causes Potential Image Loss

    Verathon recalls 1,706 GlideScope Core 15-inch FHD monitors due to a software defect in versions v1.7 and earlier. The defect can cause loss or degradation of image when the monitor is used with other connectable devices.

    Product
    Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software Version: Core 15 FHD v1.7 and earlier Product Description: Serialized Monitor
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1983-2024·2024-06-12

    Vascular graft separation defect recalled by Atrium Medical

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of internal components. The defect affects over 53,000 units distributed worldwide.

    Product
    ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1997-2024·2024-06-12

    Vascular Graft Component Separation in ADVANTA VXT Medical Devices

    ADVANTA VXT vascular grafts are being recalled because the Slider GDS Swivel Rod may separate from the Swivel Core. This affects about 53,308 units distributed worldwide including the US.

    Product
    ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1996-2024·2024-06-12

    ADVANTA VXT Vascular Grafts Recalled for Slider Component Separation Risk

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Approximately 53,308 units worldwide are affected.

    Product
    ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-1988-2024·2024-06-12

    Vascular graft component separation risk: ADVANTA VXT slider rod defect

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of separation between the Slider GDS Swivel Rod and Swivel Core, potentially affecting device functionality.

    Product
    ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1945-2024·2024-06-12

    Proton Therapy System May Continue Irradiation When Accelerator Control Parameters Out of Tolerance

    Ion Beam Applications' IBA Proton Therapy System PROTEUS 235 may continue delivering radiation when critical accelerator control parameters are outside defined tolerances. Affected users should contact the manufacturer regarding firmware updates.

    Product
    IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2024·2024-06-12

    ADVANTA VXT Vascular Graft Slider Component Separation Recall

    Atrium Medical Corporation is recalling its ADVANTA VXT vascular graft due to reports that the Slider GDS Swivel Rod can separate from the Swivel Core, creating a gap between components.

    Product
    ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-1994-2024·2024-06-12

    Vascular graft recalled due to slider component separation risk

    Atrium Medical's ADVANTA VXT vascular grafts are being recalled worldwide due to reports of the Slider GDS Swivel Rod separating from the Swivel Core. The separation creates a gap that could compromise device function.

    Product
    ADVANTA VXT, 4-7X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2024·2024-06-12

    FLIXENE Vascular Graft Recall for Swivel Rod Component Separation

    Atrium Medical is recalling FLIXENE vascular grafts due to complaints of separation between the Swivel Rod and Swivel Core components. The recall affects 53,308 units worldwide, including 11,236 in the US.

    Product
    FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1991-2024·2024-06-12

    Vascular graft devices subject to swivel rod separation from core assembly

    Atrium Medical Corporation is recalling ADVANTA VXT vascular graft devices due to reports of the swivel rod separating from the core. The separation could compromise device function.

    Product
    ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2000-2024·2024-06-12

    Vascular Graft Recalled Due to Potential Component Separation Risk

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to complaints of separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units have been distributed worldwide.

    Product
    ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-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-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-1974-2024·2024-06-12

    Vascular graft component separation in Atrium Medical ADVANTA VXT devices

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts worldwide due to reports of separation between the swivel rod and swivel core. The component failure could affect graft function.

    Product
    ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1982-2024·2024-06-12

    Vascular Graft Component Separation Risk in ADVANTA VXT Grafts

    ADVANTA VXT vascular grafts are being recalled due to reported separation of the Slider GDS Swivel Rod from its core. This mechanical failure could compromise graft function.

    Product
    ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1973-2024·2024-06-12

    Atrium ADVANTA VXT Vascular Graft Slider Rod Separation

    ADVANTA VXT vascular grafts may have separation of the Slider GDS Swivel Rod from the Swivel Core. Atrium is recalling affected units.

    Product
    ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2024·2024-06-12

    Vascular graft component separation: Atrium Medical ADVANTA VXT recall

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the slider mechanism from the core component, which could compromise device integrity.

    Product
    ADVANTA VXT, 7X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. 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-1963-2024·2024-06-12

    Atrium Medical Vascular Graft Swivel Component Separation Recall

    Atrium Medical recalled 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the swivel rod from the swivel core. The affected units were distributed throughout the United States and to 60 additional countries.

    Product
    ADVANTA VXT, 6X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1936-2024·2024-06-12

    Medline Syringes Recalled Due to Leaks, Breakage, and Quality Issues

    Medline Industries is recalling over 2.3 million syringes due to identified leaks, breakage, and quality issues that may pose risks to patient health. The affected syringes were distributed nationwide and internationally.

    Product
    Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, Item Number: DYNJSYRPP20R; d) SYRINGE 10ML RED L/L LOW PR, Item Number: DYN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1952-2024·2024-06-12

    Vascular graft recall: Advanta VXT swivel rod separation

    Atrium Medical recalls Advanta VXT vascular grafts due to swivel rod separation from the core component. Approximately 53,308 units are affected worldwide.

    Product
    ADVANTA VXT, 6X40, 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-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-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-2002-2024·2024-06-12

    Vascular graft separation risk affects FLIXENE slider GDS devices

    Atrium Medical recalls FLIXENE vascular grafts due to complaints of slider rod separation from the swivel core, which could affect device function.

    Product
    FLIXENE, 6X50, 1GDS, GW. 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-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-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-1953-2024·2024-06-12

    Vascular Graft Device Recalled for Slider Component Separation

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the slider component from the swivel core. The recall affects 53,308 units worldwide.

    Product
    ADVANTA VXT, 8X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    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-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 (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-1985-2024·2024-06-12

    Vascular Graft Swivel Rod Separation Recalled Due to Component Failure

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reports of separation between the Slider GDS Swivel Rod and Swivel Core, which could affect device function.

    Product
    ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2019-2024·2024-06-12

    Quality Control Tool Vitamin B12 Range Verifier Recalled by FDA

    Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Range Verifier Lot 1200 because the product may fail to verify required calibration range. The failure is detectable during use and does not affect actual patient test results.

    Product
    VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0543-2024·2024-06-12

    Estradiol transdermal patches recalled for failed quality specifications

    Zydus Pharmaceuticals is recalling 13,440 units of Estradiol transdermal patches distributed nationwide due to failed impurities and degradation specifications. No illnesses or injuries have been reported.

    Product
    ESTRADIOL — ESTRADIOL (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1947-2024·2024-06-12

    Leica HistoCore PEGASUS tissue processor recalled for tissue damage

    LEICA BIOSYSTEMS is recalling 141 Leica HistoCore PEGASUS tissue processors due to reagent overfilling that causes poorly processed or damaged biopsy tissue specimens.

    Product
    Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1284-2024·2024-06-12

    Charles Boggini Pink Lemonade Recalled for Undeclared Food Dye

    Charles Boggini Pink Lemonade in 1 and 5-gallon sizes is recalled for containing undeclared FD&C Red No. 40. The colorant was not listed on product labels.

    Product
    Charles Boggini Pink Lemonde; 1 or 5 U.S. Gallons
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0542-2024·2024-06-12

    Estradiol Transdermal Patch Recalled for Failed Chemical Specifications

    Zydus Pharmaceuticals is recalling Estradiol Transdermal System patches nationwide due to failed impurities and degradation specifications. The recall affects 21,360 units distributed throughout the United States.

    Product
    ESTRADIOL — ESTRADIOL (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0538-2024·2024-06-12

    Cephalexin Oral Suspension Recalled for Incorrect Dosage Label

    Bryant Ranch Prepack is recalling Cephalexin oral suspension because the back label incorrectly states the bottle contains 5g instead of 10g. No illnesses have been reported.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0544-2024·2024-06-12

    TIVICAY HIV medication carton mislabeled with incorrect expiration date

    GlaxoSmithKline recalls TIVICAY cartons nationwide with incorrect expiration date on packaging. The carton label shows May 2026, but the correct expiration on the bottle is April 2025.

    Product
    TIVICAY — TIVICAY (DOLUTEGRAVIR SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0537-2024·2024-06-12

    Cephalexin oral suspension recalled for incorrect label dosage amount

    Bryant Ranch Prepack is recalling Cephalexin oral suspension (125mg/5mL) due to back label errors stating the dose as 2.5g instead of the correct 5g per bottle. No illnesses have been reported.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1286-2024·2024-06-12

    Charles Boggini Yellow Lemonade Recalled for Undeclared Yellow No. 5

    Charles Boggini Company is recalling Yellow Lemonade and Yellow Lemonade X (1 and 5 gallon sizes) due to undeclared FD&C Yellow No. 5. Consumers with tartrazine sensitivity should not consume the affected products.

    Product
    Charles Boggini Company Yellow Lemonade and Yellow Lemonade X; 1 gallon and 5 gallons
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0540-2024·2024-06-12

    Cephalexin oral suspension recalled for incorrect dose labeling

    Bryant Ranch Prepack is recalling 61 bottles of Cephalexin for Oral Suspension due to a back label stating an incorrect dose amount—5g instead of 10g per bottle.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2026-2024·2024-06-12

    Surgical imaging device electrical component may intermittently shut off

    The O-arm O2 surgical imaging system may experience intermittent electrical failure affecting intraoperative imaging guidance. The recall involves 20 units distributed in the US and internationally.

    Product
    O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0539-2024·2024-06-12

    Cephalexin for Oral Suspension Recalled for Back Label Error

    Cephalexin for Oral Suspension is being recalled due to a back label error. The label states 'Each contains' instead of 'Each Bottle contains,' affecting 190 bottles distributed nationwide.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V425000·2024-06-11

    New Flyer Recalls 2023 Buses Due to Fuel Hose Separation Risk

    New Flyer is recalling 2023 XD35, XD40, and XD60 buses because fuel filter hoses may separate, causing leaks or engine stalls.

    Product
    NEW FLYER — NEW FLYER XD35, XD40, XD60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24E048000·2024-06-10

    Dana Recalls D-Series and E-Series Steer Axles Due to Tie Rod Defect

    Dana Incorporated is recalling D-Series and E-Series steer axles and replacement tie rod assemblies because incorrectly heat-treated ball studs may break, potentially causing loss of steering control.

    Product
    STEERING:LINKAGES:TIE ROD ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24E049000·2024-06-10

    Waymo Recalls 5th Generation Automated Driving Systems for Software Defect

    Waymo is recalling 672 5th Generation Automated Driving Systems due to a software defect that could prevent the system from avoiding poles or similar objects.

    Product
    ELECTRICAL SYSTEM:ADAS:AUTONOMOUS/SELF DRIVING:SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V428000·2024-06-10

    Audi Recalls 2024 Q8 E-Tron Models for Brake Line Defect

    Volkswagen is recalling 2024 Audi Q8 E-Tron vehicles because an over-tightened brake line connection may leak fluid, reducing braking ability and increasing crash risk.

    Product
    AUDI — AUDI Q8 SPORTBACK E-TRON, Q8 E-TRON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-06102024-01·2024-06-10

    USDA Issues Public Health Alert for Misbranded Southwestern Salad Bowls

    USDA FSIS issued a public health alert for Bistro Grande Southwestern Style salad bowls containing undeclared wheat and fish allergens.

    Product
    FSIS Issues Public Health Alert For Southwestern Style Salad Bowls With Chicken Due To Misbranding And Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·24V423000·2024-06-09

    Volvo Recalls 2025 VN Trucks for Steering Control Loss Risk

    Volvo Trucks North America is recalling 2025 VN trucks because improperly heat-treated tie rod assemblies may fail, causing sudden loss of steering control.

    Product
    VOLVO — VOLVO VN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V424000·2024-06-09

    Mack Trucks Recalls 2025 Anthem and Pinnacle Models for Steering Defect

    Mack Trucks is recalling 2025 Anthem and Pinnacle trucks because improperly heat-treated ball studs in the tie rod assemblies may fail, causing a sudden loss of steering control.

    Product
    MACK — MACK PIONEER PR (4), ANTHEM (AN)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-06072024-01·2024-06-07

    Frozen Bao Curry Chicken Recalled for Undeclared Soy and Sesame Allergens

    USDA FSIS issued a public health alert for frozen bao curry chicken products that may contain undeclared soy and sesame allergens.

    Product
    Brett Anthony Foods — FSIS Issues Public Health Alert for Frozen Ready-To-Eat Bao Curry Chicken Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·24V422000·2024-06-07

    2024 KIA Sportage Power Steering System Circuit Board Failure

    Kia is recalling certain 2024 Sportage vehicles because the motor-driven power steering circuit board may short circuit, causing loss of steering assist and increased crash risk. Owners should contact Kia at 1-800-333-4542 for a free replacement.

    Product
    KIA — KIA SPORTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·24254·2024-06-06

    Good Earth Rechargeable Integrated Lights Recalled for Fire and Burn Hazards

    Good Earth Lighting is recalling more than 1.2 million rechargeable integrated lights whose lithium-ion batteries can overheat and ignite the plastic housing, posing fire and burn hazards. One death has been reported.

    Product
    Good Earth Rechargeable Integrated Lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·24E046000·2024-06-06

    Mando Power Steering Module Recall Due to Short Circuit Risk

    Mando America is recalling Motor Driven Power Steering Power Packs where a short circuit may cause loss of steering assist, increasing crash risk.

    Product
    STEERING:STEERING CONTROL MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V420000·2024-06-06

    Freightliner Custom Chassis Trucks Recalled for Fuel Hose Separation Risk

    Daimler Trucks North America is recalling 2023-2024 Freightliner Custom Chassis XCR, XBS, and XCM trucks because remote fuel filter hoses may separate, causing fuel leaks or engine stalls.

    Product
    FCCC — FCCC XCR, XBS, XCM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V417000·2024-06-06

    Foretravel Recalls 2020 IC-37 Motorhomes Due to Fire Risk

    Foretravel is recalling 2020 IC-37 motorhomes because a circuit unit may overheat and cause a fire. Dealers will install a protection module free of charge.

    Product
    FORETRAVEL — FORETRAVEL IC-37
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24256·2024-06-06

    Kawasaki Engines in Multiple Lawn Equipment Brands Recalled for Fire and Burn Hazard

    Kawasaki is recalling approximately 68,500 engines used in lawn and garden equipment from multiple brands due to overheating that can cause fire and burn hazards. Consumers should stop using affected equipment and contact the manufacturer or an authorized dealer for free repair.

    Product
    Kawasaki Engines used in Bad Boy Mowers, BigDog, Bobcat, Cub Cadet, Hustler, John Deere, and Kubota brand lawn and garden equipment
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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