The Recall Desk

Archive

December 2023 recalls

600 recalls were announced in December 2023.

What the numbers show

Critical
29
Severe
210
High
310
Moderate
49
Low
2

Of the 600 recalls this month scored against our rubric, 5% are Critical, 35% are Severe.

201–300 of 600

  • SevereFDA (Food)·F-0556-2024·2023-12-20

    Wilcox Premium Black Forest ice cream recalled for Listeria contamination

    Wilcox Premium Black Forest ice cream is recalled for possible Listeria monocytogenes contamination. The recall affects products distributed to VT, NH, MA, and NY with Best By dates from 9/14/24 to 11/14/24.

    Product
    Wilcox Premium Black Forest in 1.5QT, Quart, Pint, and 3 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0550-2024·2023-12-20

    Wilcox Premium Cookie Dough Ice Cream Recalled for Listeria Contamination

    Wilcox Ice Cream is recalling Premium Cookie Dough ice cream due to potential Listeria monocytogenes contamination. Products dated 9/14/24–11/14/24 were distributed in VT, NH, MA, and NY.

    Product
    Wilcox Premium Cookie Dough in 1.5QT, Quart, Pint, and 3 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0591-2024·2023-12-20

    Acorn Raspberry Cookies Recalled for Undeclared Tree Nut Allergen

    Houdini Inc. is recalling Acorn Raspberry Creme Filled Cookies sold in gift baskets due to undeclared tree nuts. Consumers with tree nut allergies should not consume the product.

    Product
    Acorn Raspberry Creme Filled Cookie found in gift basket: #342 Bakery Bonanza
    Category
    Food
    Distribution
    50 states
  • SevereFDA (Food)·F-0598-2024·2023-12-20

    Maggi 2-Minute Noodles Recalled for Undeclared Peanut Allergen

    Maggi 2-Minute Noodles are being recalled due to undeclared peanut allergen. Consumers with peanut allergies should not consume affected products sold in California retail stores.

    Product
    Maggi 2-Minute Noodles; 280g (24 packets/case); plastic pouch; store in a cool dry place
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0523-2024·2023-12-20

    Wilcox Yogurt recalled for potential Listeria monocytogenes contamination

    Wilcox Yogurt - Black Raspberry pints are being recalled due to potential Listeria monocytogenes contamination. Affected products with specific Best By dates were distributed in VT, NH, MA, and NY.

    Product
    Wilcox Yogurt - Black Raspberry; Pint (UPC 04372600695)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0594-2024·2023-12-20

    Acorn Raspberry Creme Cookies Recalled for Undeclared Tree Nut Allergen

    Houdini Inc. is recalling 4,875 Acorn Raspberry Creme Filled Cookies from gift baskets due to undeclared tree nut allergen. These products were distributed across all U.S. states.

    Product
    Acorn Raspberry Creme Filled Cookie found in gift basket: #373 Cookie, Brownie and Cake Winter Assortment
    Category
    Food
    Distribution
    50 states
  • SevereFDA (Devices)·Z-0505-2024·2023-12-20

    Philips Panorama MR System Structural Failure Risk from Helium Gas Pressure

    Philips Panorama 1.0T MR Systems (Models 781250, 781350) may experience structural failure during helium quench events, releasing pressurized gas and debris that could cause helium exposure, asphyxia, and injury to patients and operators.

    Product
    Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Food)·F-0597-2024·2023-12-20

    Acorn Raspberry Creme Filled Cookie Recall Due to Undeclared Tree Nuts

    Houdini Inc. is recalling Acorn Raspberry Creme Filled Cookies in gift basket #927 due to undeclared tree nut allergen. The cookies were distributed nationwide.

    Product
    Acorn Raspberry Creme Filled Cookie found in gift basket: #927 Fresh Baked Cookie, Brownie and Cake Collection
    Category
    Food
    Distribution
    50 states
  • SevereFDA (Food)·F-0509-2024·2023-12-20

    Wilcox Premium Chocolate Ice Cream Recalled for Listeria Contamination

    Wilcox Premium Chocolate ice cream is recalled for potential Listeria monocytogenes contamination. Products with Best By dates 9/14/24–11/14/24 distributed in VT, NH, MA, and NY are affected.

    Product
    Wilcox Premium Chocolate; 4 oz Cup; UPC 04372600402; Wilcox Premium Chocolate in 1.5QT, Quart, Pint, 3 Gallon, and 1 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0530-2024·2023-12-20

    Leonardo's Gelato Maple Gelato recalled for potential Listeria contamination

    WILCOX ICE CREAM is recalling Leonardo's Gelato Maple Gelato pints due to potential Listeria monocytogenes contamination. Affected products were distributed in VT, NH, MA, and NY with best-by dates from 8/28/24 to 11/14/24.

    Product
    Leonardo's Gelato Maple Gelato; Pints (UPC 8 1643900055)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0529-2024·2023-12-20

    Wilcox Ice Cream Bars recalled for potential Listeria contamination

    Wilcox Ice Cream Bar (Pumpkin) products may be contaminated with Listeria monocytogenes. Affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York with best-by dates from September 15 to November 14, 2024.

    Product
    Wilcox Ice Cream Bar (Dairy Based) Pumpkin ; (UPC 043726005010)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0549-2024·2023-12-20

    Wilcox ice cream recall due to potential Listeria monocytogenes contamination

    Wilcox Premium Catamount Tracks ice cream sold in VT, NH, MA, and NY may be contaminated with Listeria monocytogenes. The Class I recall affects 19.31 tons with Best By dates from 9/14/24 to 11/14/24.

    Product
    Wilcox Premium Catamount Tracks in 1.5QT, Quart, Pint, and 3 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0553-2024·2023-12-20

    Wilcox Premium Pink Cupcake Party Ice Cream recalled for Listeria contamination

    Wilcox Premium Pink Cupcake Party ice cream in multiple sizes is being recalled due to potential Listeria monocytogenes contamination affecting products in VT, NH, MA, and NY.

    Product
    Wilcox Premium Pink Cupcake Party in 1.5QT, Quart, Pint, and 3 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0528-2024·2023-12-20

    Wilcox Ice Cream Bars Recalled for Potential Listeria Contamination

    Wilcox Ice Cream Bar in Maple Cream flavor is being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York.

    Product
    Wilcox Ice Cream Bar (Dairy Based) Maple Cream; (UPC 043726005096)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0522-2024·2023-12-20

    Wilcox Yogurt Recalled for Potential Listeria Monocytogenes Contamination

    Wilcox Yogurt - Maple Cream pints sold in Vermont, New Hampshire, Massachusetts, and New York are recalled due to potential Listeria monocytogenes contamination.

    Product
    Wilcox Yogurt - Maple Cream; Pint (UPC 04372600698)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0540-2024·2023-12-20

    Wilcox Premium Strawberry Ice Cream Recalled Due to Listeria Risk

    Wilcox Premium Strawberry ice cream in multiple sizes distributed in VT, NH, MA, and NY may contain Listeria monocytogenes. Consumers should discard affected products.

    Product
    Wilcox Premium Strawberry in 1.5QT, Quart, Pint, 3 Gallon, and 1 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0521-2024·2023-12-20

    Wilcox Vanilla Yogurt Recalled Due to Listeria Contamination Risk

    Wilcox Vanilla Yogurt pints are recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in VT, NH, MA, and NY with Best By dates in October 2024.

    Product
    Wilcox Yogurt - Vanilla; Pint (UPC 04372600699)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0560-2024·2023-12-20

    Wilcox Premium Double Chocolate Ripple ice cream recalled for Listeria contamination

    Wilcox Premium Double Chocolate Ripple ice cream in multiple sizes is being recalled due to potential Listeria monocytogenes contamination. Consumers should discard or return affected products.

    Product
    Wilcox Premium Double Chocolate Ripple in 1.5QT, Quart, and Pint sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0546-2024·2023-12-20

    Wilcox Premium Fudge Ripple ice cream recalled for Listeria monocytogenes contamination

    Wilcox Premium Fudge Ripple ice cream is being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York.

    Product
    Wilcox Premium Fudge Ripple in 1.5QT, Quart, Pint, and 3 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0534-2024·2023-12-20

    Leonardo's Gelato Mint Chocolate Chip Recalled Due to Listeria Contamination

    Leonardo's Gelato Mint Chocolate Chip (pints and 4 oz cups) may be contaminated with Listeria monocytogenes. Products were distributed in VT, NH, MA, and NY with Best By dates from August 28–November 14, 2024.

    Product
    Leonardo's Gelato Mint Chocolate Chip; Pints (UPC 8 1643900050) and 4 oz cup (UPC 81643900041)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0531-2024·2023-12-20

    Leonardo's Gelato recalled due to possible Listeria monocytogenes contamination

    Leonardo's Gelato Sams Creamy Chocolate Chip products are being recalled due to possible Listeria monocytogenes contamination. The recall affects pints and 4 oz cups distributed in Vermont, New Hampshire, Massachusetts, and New York.

    Product
    Leonardo's Gelato Sams Creamy Chocolate Chip; Pints (UPC 8 1643900019) and 4 oz cup (UPC 81643900040)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0555-2024·2023-12-20

    Wilcox Premium Peppermint Ice Cream Recalled for Possible Listeria Contamination

    Wilcox Ice Cream is recalling Wilcox Premium Peppermint ice cream in multiple sizes distributed in Vermont, New Hampshire, Massachusetts, and New York due to possible Listeria monocytogenes contamination.

    Product
    Wilcox Premium Peppermint in 1.5QT, Quart, Pint, and 3 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0585-2024·2023-12-20

    Mixed Fruit Products Recalled for Possible Salmonella Contamination

    Cut Fruit Express is recalling mixed fruit products containing cantaloupe, honeydew, and red grapes due to potential Salmonella contamination. Affected products were distributed in Illinois, Minnesota, and Wisconsin.

    Product
    Mixed Fruit Products that contain Cantaloupe, Honeydew, and Red Grapes, Identified with the following Item ID and Description. 1. 8366011 FRUIT MIX CHG DICED 1/2" 25lbs. 2. 7224471 Fruit Mix CHG 5lb. 3. 92556 Fruit Mix, CrGH 40-1/2 Cup /40
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0578-2024·2023-12-20

    Multiple fruit products recalled due to possible Salmonella contamination

    Vinyard Fruit & Vegetable Co. is recalling multiple fruit products distributed in Oklahoma due to possible Salmonella contamination. The recall includes Fruit Medley Cups, Cantaloupe Cubes, and Melon variety packs.

    Product
    Fruit Medley Cup 16/6 oz 3300-3 Cantaloupe Cube (2/5 lb) 3338-3 Fruit Mix Kit (4/5 lb) (Tray) 2963-3 3 Melon 16/6 oz cups 3330-3 Fruit Mix (2/5 lb) 3301-3 Cantaloupe Cube (5 lb) 3304-3 Cantaloupe Cubed 10/12 oz cups 0526-3 Melon Variety Pack 2964-3 3 Melon Medley 6 oz cups 2973-3
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0520-2024·2023-12-20

    Wilcox Vanilla Ice Cream Recalled for Possible Listeria Contamination

    Wilcox SUPER PREMIUM Vanilla ice cream (1.5 QT and Pint sizes) may be contaminated with Listeria monocytogenes. Products were distributed in Vermont, New Hampshire, Massachusetts, and New York with best-by dates September 13 to November 14, 2024.

    Product
    Wilcox SUPER PREMIUM Vanilla; 1.5 QT (UPC 04372601519) and Pint (UPC 04372601619)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0548-2024·2023-12-20

    CereLink ICP Extension Cable Recalled for Out of Range Readings

    Integra LifeSciences is recalling CereLink ICP Extension Cables due to a design defect causing out of range readings. The Class I recall affects 4,941 units distributed nationwide and internationally.

    Product
    CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0535-2024·2023-12-20

    Leonardo's Gelato Maple Flavor Recalled for Possible Listeria Contamination

    WILCOX ICE CREAM is recalling Leonardo's Gelato VT Maple Gelato 4 oz cups due to possible Listeria monocytogenes contamination. Affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York.

    Product
    Leonardo's Gelato VT Maple Gelato; 4 oz Cup (UPC 81643900056)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0554-2024·2023-12-20

    Wilcox Premium Triple Chocolate Cookie ice cream recalled for Listeria contamination

    Wilcox Premium Triple Chocolate Cookie ice cream is recalled for potential Listeria monocytogenes contamination. Affected products in Vermont, New Hampshire, Massachusetts, and New York have best-by dates from September through November 2024.

    Product
    Wilcox Premium Triple Chocolate Cookie in 1.5QT, Quart, Pint, and 3 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0557-2024·2023-12-20

    Wilcox Premium Maple Cheesecake ice cream recalled for potential Listeria contamination

    Wilcox Ice Cream is recalling Wilcox Premium Maple Cheesecake due to potential Listeria monocytogenes contamination. Affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York.

    Product
    Wilcox Premium Maple Cheesecake in 1.5QT, Quart, Pint, and 3 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0518-2024·2023-12-20

    Wilcox SUPER PREMIUM Mint Chunk ice cream recalled for Listeria

    Wilcox SUPER PREMIUM Mint Chunk ice cream is being recalled due to potential Listeria monocytogenes contamination. The recall affects products distributed in VT, NH, MA, and NY with Best By dates between September 13 and November 14, 2024.

    Product
    Wilcox SUPER PREMIUM Mint Chunk; 1.5 QT (UPC 04372601512) and Pint (UPC 04372601612)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0547-2024·2023-12-20

    Wilcox Premium Raspberry Cheesecake Ice Cream Recalled for Listeria Contamination

    Wilcox Premium Raspberry Cheesecake ice cream may be contaminated with Listeria monocytogenes. The recall affects products distributed in Vermont, New Hampshire, Massachusetts, and New York with best-by dates from 9/14/24 to 11/14/24.

    Product
    Wilcox Premium Raspberry Cheesecake in 1.5QT, Quart, Pint, and 3 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0548-2024·2023-12-20

    Wilcox Premium Blueberry Crumble ice cream recalled for potential Listeria contamination

    WILCOX ICE CREAM is recalling Wilcox Premium Blueberry Crumble ice cream in multiple sizes due to potential Listeria monocytogenes contamination. The affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York.

    Product
    Wilcox Premium Blueberry Crumble in 1.5QT, Quart, Pint, and 3 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0551-2024·2023-12-20

    Wilcox Premium Pumpkin ice cream recalled due to Listeria contamination

    Wilcox Premium Pumpkin ice cream in multiple sizes is being recalled due to potential Listeria monocytogenes contamination. Affected products distributed in VT, NH, MA, and NY with Best By dates from September to November 2024.

    Product
    Wilcox Premium Pumpkin in 1.5QT, Quart, Pint, and 3 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0517-2024·2023-12-20

    Wilcox ice cream recalled for possible Listeria contamination

    Wilcox SUPER PREMIUM Maple Walnut ice cream may contain Listeria monocytogenes. The recall affects products sold in Vermont, New Hampshire, Massachusetts, and New York with best-by dates from September through November 2024.

    Product
    Wilcox SUPER PREMIUM Maple Walnut; 1.5 QT (UPC 04372601511) and Pint (UPC 04372601611)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0584-2024·2023-12-20

    Mixed Fruit Products Recalled for Potential Salmonella Contamination

    Cut Fruit Express, Inc. is recalling mixed fruit products containing cantaloupe, honeydew, and pineapple due to potential Salmonella contamination. The recall affects 21 units distributed in Illinois, Minnesota, and Wisconsin.

    Product
    Mixed Fruit Products that contain Cantaloupe, Honeydew, and Pineapple, Identified with the following Item ID and Description. 1. 5094954 Fruit Mix CHP Diced 3/4"" 4-5 lb. 2. 5893058 Fruit Mix CHP 5lb.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0552-2024·2023-12-20

    Wilcox Premium Peanut Butter Fudge Swirl ice cream recalled for Listeria

    Wilcox Premium Peanut Butter Fudge Swirl ice cream sold in VT, NH, MA, and NY may contain Listeria monocytogenes. Affected products have Best By dates from 9/14/24–11/14/24 and should not be consumed.

    Product
    Wilcox Premium Peanut Butter Fudge Swirl in 1.5QT, Quart, Pint, and 3 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0563-2024·2023-12-20

    Wilcox Premium Butterscotch Ripple Ice Cream Recalled Due to Listeria Risk

    Wilcox Premium Butterscotch Ripple ice cream in multiple sizes is being recalled due to potential contamination with Listeria monocytogenes. The recall affects 19.31 tons distributed in VT, NH, MA, and NY with Best By dates from 9/14/24 to 11/14/24.

    Product
    Wilcox Premium Butterscotch Ripple in 1.5QT, Quart, and Pint sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0513-2024·2023-12-20

    Wilcox Premium Black Raspberry Ice Cream Recalled for Potential Listeria Contamination

    Wilcox Premium Black Raspberry ice cream has been recalled due to potential contamination with Listeria monocytogenes. The recall affects products distributed in Vermont, New Hampshire, Massachusetts, and New York with best-by dates from September to November 2024.

    Product
    Wilcox Premium Black Raspberry; 4 oz Cup; UPC 04372600406; Wilcox Premium Black Raspberry in 1.5QT, Quart, Pint, 3 Gallon, and 1 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0595-2024·2023-12-20

    Acorn Raspberry Creme Cookies Recalled for Undeclared Tree Nuts

    Houdini Inc. is recalling Acorn Raspberry Creme Filled Cookies found in gift basket #925 due to undeclared tree nuts. The product poses a health risk to consumers with tree nut allergies.

    Product
    Acorn Raspberry Creme Filled Cookie found in gift basket: #925 Bakery, Coffee & Cocoa Gift Collection
    Category
    Food
    Distribution
    50 states
  • SevereFDA (Food)·F-0536-2024·2023-12-20

    Wilcox Premium Cookies in Cream ice cream recalled for Listeria

    Wilcox Premium Cookies in Cream ice cream in multiple sizes is being recalled due to possible Listeria monocytogenes contamination. Affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York with best-by dates between September 14 and November 14, 2024.

    Product
    Wilcox Premium Cookies in Cream in 1.5QT, Quart, Pint, 3 Gallon, and 1 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0559-2024·2023-12-20

    Wilcox Premium Cream and Coffee Fudge recalled for Listeria contamination

    Wilcox Premium Cream and Coffee Fudge ice cream in multiple sizes is being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York with Best By dates from September through November 2024.

    Product
    Wilcox Premium Cream and Coffee Fudge in 1.5QT, Quart, and Pint sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0618-2024·2023-12-20

    Cantaloupes Recalled Due to Salmonella Contamination Risk

    Crown Jewels Produce Company is recalling Malichita/Z Farms Cantaloupes due to potential Salmonella contamination. The affected cantaloupes were distributed in California and Ohio.

    Product
    Malichita/Z Farms Cantaloupes 35 to 40 lb. cartons sold by piece count.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0586-2024·2023-12-20

    Cut Fruit Express Mixed Fruit Products Recalled for Salmonella Contamination

    Cut Fruit Express is recalling mixed fruit products containing cantaloupe due to potential Salmonella contamination. Products were distributed in Illinois, Minnesota, and Wisconsin.

    Product
    Mixed Fruit Products that contain Cantaloupe, Honeydew, Pineapple, Watermelon and Red Grapes, Identified with the following Item ID and Description. 1. 1082858 Fruit Mix CrGHPW 5lb. 2. 4786 Five Fruit Blend CHPWG 32oz
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0532-2024·2023-12-20

    Leonardo's Gelato Chocolate Gelato Recalled for Listeria Contamination

    Wilcox Ice Cream is recalling Leonardo's Gelato Chocolate Gelato due to potential Listeria monocytogenes contamination. The recall affects pints and 4 oz cups distributed in Vermont, New Hampshire, Massachusetts, and New York.

    Product
    Leonardo's Gelato Chocolate Gelato; Pints (UPC 8 1643900005) and 4 oz cup (UPC 81643900028)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0542-2024·2023-12-20

    Wilcox Premium Chocolate Chip Ice Cream Recalled Due to Listeria Contamination

    Wilcox Premium Chocolate Chip ice cream is being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in VT, NH, MA, and NY with best-by dates from September 14 to November 14, 2024.

    Product
    Wilcox Premium Chocolate Chip in 1.5QT, Quart, Pint, and 3 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0561-2024·2023-12-20

    Wilcox Premium Sweet Cream recalled for potential Listeria contamination

    Wilcox Premium Sweet Cream in multiple sizes with Best By dates 9/14/24 to 11/14/24 is being recalled due to potential Listeria monocytogenes contamination. Products were distributed in Vermont, New Hampshire, Massachusetts, and New York.

    Product
    Wilcox Premium Sweet Cream in 1.5QT, Quart, and Pint sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0564-2024·2023-12-20

    Wilcox Premium Chocolate Raspberry Truffle ice cream recalled for Listeria contamination

    Wilcox Premium Chocolate Raspberry Truffle ice cream is recalled for potential Listeria monocytogenes contamination. Products distributed in VT, NH, MA, and NY with Best By dates 9/14/24–11/14/24 are affected.

    Product
    Wilcox Premium Chocolate Raspberry Truffle in 1.5QT, Quart, and Pint sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0545-2024·2023-12-20

    Wilcox Premium French Vanilla ice cream recalled for Listeria contamination risk

    Wilcox Premium French Vanilla ice cream may be contaminated with Listeria monocytogenes. The affected products were distributed in VT, NH, MA, and NY with Best By dates between 9/14/24 and 11/14/24.

    Product
    Wilcox Premium French Vanilla in 1.5QT, Quart, Pint, and 3 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0527-2024·2023-12-20

    Wilcox Peanut Butter Ice Cream Bars Recalled for Listeria Contamination

    Wilcox Peanut Butter Ice Cream Bars are being recalled in Vermont, New Hampshire, Massachusetts, and New York due to potential Listeria monocytogenes contamination. Affected products have best-by dates from 9/15/24 through 11/14/24.

    Product
    Wilcox Ice Cream Bar (Dairy Based) Peanut Butter; (UPC 043726005089)
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0524-2024·2023-12-20

    Medical Device Recall: PHYSICA HPS Tibial Liner Incorrect Labeling

    Limacorporate is recalling 33 PHYSICA HPS Tibial Liner units distributed in the U.S. due to incorrect product labeling. No adverse events have been reported.

    Product
    PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-0571-2024·2023-12-20

    Frozen shrimp and other foods recalled due to temperature abuse

    Ben E Keith Foods is recalling frozen and refrigerated shrimp and other food products that were temperature abused while stored in a food trailer. The products were distributed to food service establishments.

    Product
    SHRIMP RAW P&D WHITE 16-20 CT
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·23V867000·2023-12-20

    Audi E-Tron Battery Modules May Overheat Creating Fire Risk

    Audi is recalling 2019-2022 E-Tron vehicles because high-voltage battery modules may overheat and increase fire risk. Dealers will install diagnostic software and replace affected modules at no cost.

    Product
    AUDI — AUDI E-TRON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0534-2024·2023-12-20

    Medline Leg Bags Recalled Due to Undeclared Latex

    Medline Industries has recalled approximately 19,406 leg bags due to undeclared latex. Patients with latex allergies may experience allergic reactions from skin contact with the device.

    Product
    Medline Leg bag, REF DYND12578
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·23V866000·2023-12-20

    2023 Nova Bus LFS Suspension Hardware May Separate

    Nova Bus is recalling 2023 LFS buses because the front air spring suspension hardware may separate from its attachment plate, potentially causing sudden loss of suspension and vehicle control.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V864000·2023-12-20

    2022-2023 Toyota Corolla Cross air bag deployment defect recall

    Toyota is recalling 2022-2023 Corolla Cross vehicles where instrument panel defects may prevent the front-passenger air bag from deploying in a crash. Dealers will replace the panel at no cost.

    Product
    TOYOTA — TOYOTA COROLLA CROSS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0575-2024·2023-12-20

    Frozen Vegetable Products Recalled Due to Temperature Abuse During Transport

    Ben E Keith Foods is recalling approximately 1,721 cases of multiple frozen vegetable and side-dish products due to temperature abuse during shipment. Consumers should discard affected products.

    Product
    TATER KEG BACON CHEDDAR CHIVE; OKRA CUT HEAVILY BREADED IQF; POTATO TATER TOTS; FRENCH FRIES SC 3/8 IN; JALAPENO STUFFED W/CHDR CHS; CORN CUT; BEAN GREEN REGULAR CUT; BEAN GREEN SPICY BREADED; ONION RING BEER BATTERED 5/8IN; PICKLE FRIES BREADED MUSHROOM BATTERED
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0573-2024·2023-12-20

    Frozen and Refrigerated Cheese Products Recalled Due to Temperature Abuse

    Ben E Keith Foods - Fort Worth is recalling frozen and refrigerated cheese products that were subjected to temperature abuse during storage and transport.

    Product
    CHEESE VELVEETA LOAF; CHEESE CHEDDAR SLICE MILD; CHEESE STICK MOZZ BATTERED; CHEESE CHEDDAR SLICE MILD
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·23V868000·2023-12-20

    2023-2024 Audi vehicles recalled for improperly mounted driver airbag

    Audi is recalling certain 2023-2024 models because the driver's side airbag may be improperly mounted and fail to restrain occupants correctly in a crash.

    Product
    AUDI — AUDI Q8, SQ7, RS Q8, SQ8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0659-2024·2023-12-20

    Gaw's Ham and Cheese Sub Recalled for Undeclared Sesame

    Gaws Gourmet Foods recalls Gaw's XL Ham & Cheese sub sandwiches due to undeclared sesame, a major allergen. The recall affects 357 units distributed in Michigan.

    Product
    Gaw's XL Ham & Cheese sub 8oz, Foam Tray with Clear Plastic Wrap package, UPC: 1725600925
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0505-2024·2023-12-20

    TYSON 2.0 Kava & Kratom Supplement Recalled for Unapproved Additive and pH Control Failure

    LGNDS LLC is recalling TYSON 2.0 Kava & Kratom Blend supplement because the product contains kratom, an unapproved food additive, and has a pH above safe levels for an acidified product.

    Product
    TYSON 2.0, TYSON TONIC KAVA & KRATOM BLEND, FRUIT PUNCH, 2oz (60ml), Supplement Facts, Kava Root Extract (30%) 1200mg, Kratom Leaf Extract (30%) 120mg, (Providing 36mg Mitragynine), www.tyson20global.com, LGNDS, LLC, UPC: 850043583622, POWERED BY LGNDS, 12 bottles of 2oz each per
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0504-2024·2023-12-20

    Tyson 2.0 Kava and Kratom Supplement Recalled for Unapproved Additive and pH Control Failure

    LGNDS LLC is recalling TYSON 2.0 Kava & Kratom Blend because the product contains kratom, an unapproved food additive, and has a pH level exceeding the required maximum for acidified products.

    Product
    TYSON 2.0, TYSON TONIC KAVA & KRATOM BLEND, Mocha, 2oz (60ml), Supplement Facts, Kava Root Extract (30%) 1200mg, Kratom Leaf Extract (30%) 120mg, (Providing 36mg Mitragynine), www.tyson20global.com, LGNDS, LLC, UPC: 850043583608, POWERED BY LGNDS, 12 bottles of 2oz each per case.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0658-2024·2023-12-20

    Gaw's Italian Sub Recalled for Undeclared Sesame Allergen

    Gaws Gourmet Foods is recalling Gaw's Classic Italian sub due to undeclared sesame. The recall affects 699 units distributed in Michigan; consumers who are allergic to sesame should not consume the product.

    Product
    Gaw's Classic Italian sub 8oz, Foam Tray with Clear Plastic Wrap package, UPC:1725600920
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·23V865000·2023-12-20

    Toyota and Lexus vehicles recalled for air bag sensor short circuit defect

    Toyota and Lexus are recalling certain 2020-2022 vehicles with a faulty Occupant Classification System sensor that may prevent the front passenger air bag from deploying in a crash, increasing injury risk.

    Product
    LEXUS — LEXUS, TOYOTA ES, CAMRY HYBRID, AVALON, ES HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0148-2024·2023-12-20

    Penicillamine Tablets Recalled Due to Failed Dissolution Specifications

    Lupin Pharmaceuticals is recalling Penicillamine Tablets USP 250 mg (Lot M200498) due to failed dissolution specifications. The affected tablets may not dissolve as intended, potentially affecting drug performance.

    Product
    PENICILLAMINE — PENICILLAMINE (PENICILLAMINE)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0557-2024·2023-12-20

    Olympus tracheal intubation fiberscope recalled due to suction flow specification issue

    Olympus tracheal intubation fiberscopes are being recalled because the manufacturer lacks adequate data confirming the suction flow rate meets device specifications. No injuries have been reported.

    Product
    TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0546-2024·2023-12-20

    Chemistry System Software Malfunction Causes Freezes and Result Reporting Delays

    Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to software issues causing screen freezes and system unresponsiveness. The problems can delay reporting of patient test results, including critical or STAT assays.

    Product
    VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2024·2023-12-20

    Non-sterile Betadine solution labeled and distributed as sterile

    Medline Industries is recalling 1,800 units of Sterile Betadine (Ref DYNDA1998) because the foil sachet contents are non-sterile, despite labeling that claims sterility. The recall affects units nationwide in eight states.

    Product
    STERILE BETADINE, REF DYNDA1998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0543-2024·2023-12-20

    Medical Diagnostic System Recall Due to Software-Related System Freezes and Delayed Results

    Ortho-Clinical Diagnostics is recalling the VITROS 3600 Immunodiagnostic System due to software issues causing system freezes and delayed test result reporting. The delays could affect patient care when rapid results are critical.

    Product
    VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0528-2024·2023-12-20

    Sterile PVP Medical Solution Recalled for Non-Sterile Contents

    Medline Industries is recalling 700 units of Sterile PVP solution because the labeling claims sterility but the contents are non-sterile. The affected products were distributed nationwide in eight states.

    Product
    STERILE PVP, REF DYNDA1649
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0519-2024·2023-12-20

    Para-Pak Clean Vial Stool Collection Kits Recalled for Manufacturing Defect

    Meridian Bioscience is recalling Para-Pak Clean Vials used for stool specimen collection due to a manufacturing defect that increases leakage risk and may expose users to biological hazards.

    Product
    Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0660-2024·2023-12-20

    Gaw's Ham & Cheddar Bagels recalled due to undeclared sesame allergen

    Gaws Gourmet Foods is recalling Gaw's Ham & Cheddar Bagels due to undeclared sesame. The product label does not list sesame, posing a risk to consumers with sesame allergies.

    Product
    Gaw's Ham & Cheddar Bagel 6oz, Foam Tray with Clear Plastic Wrap package, UPC:1725600500
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0570-2024·2023-12-20

    Frozen Tilapia and Tuna Products Recalled Due to Temperature Abuse

    Ben E Keith Foods is recalling 1,721 cases of frozen tilapia fillets and tuna loin products due to temperature abuse during transport. Products were distributed to food service operations.

    Product
    TILAPIA FILLET 5-7 OZ BLSL, TUNA LOIN AHI 3-5LB
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0522-2024·2023-12-20

    SynchroMed Model A10 Infusion Pump Software Display Error

    Medtronic is recalling 2,543 SynchroMed Model A10 infusion pumps with software version 1.1.300 due to missing decimal separators on parameter display screens. The omission could lead to misinterpretation of dosing parameters.

    Product
    Medtronic SynchroMed, Model A10
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0529-2024·2023-12-20

    Medline PVP Solution Recalled Due to Mislabeled Sterility

    Medline PVP Solution (REF DYNDA1858) is being recalled because it is labeled as sterile but contains non-sterile contents. 1,950 units are affected.

    Product
    PVP SOLUTION SING STRL, REF DYNDA1858
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0553-2024·2023-12-20

    X-ray system overhead suspension components may fall due to incorrect bolt torque

    GE HealthCare Definium Tempo and Tempo Pro X-ray systems may have been assembled with incorrect bolt torque, creating a risk that Overhead Tube Suspension components could fall.

    Product
    The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2024·2023-12-20

    Laboratory Diagnostic System Software Defects Cause System Freezes and Result Delays

    The VITROS 5600 laboratory analyzer is being recalled due to software issues causing screen freezes and printer disconnections that delay test result reporting, potentially affecting patient care.

    Product
    VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0544-2024·2023-12-20

    FDA Recalls VITROS 4600 Chemistry System for Software-Related Freezes

    Ortho-Clinical Diagnostics is recalling 51 units of the VITROS 4600 Chemistry System due to software defects causing system freezes and disconnections that could delay critical test result reporting.

    Product
    VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0555-2024·2023-12-20

    CARDIOHELP-i Heart-Lung Support System: Incorrectly Documented Factory Settings

    The CARDIOHELP-i Heart-Lung Support System is recalled because factory settings were incorrectly described in the manual. Healthcare providers should verify device settings with the manufacturer.

    Product
    CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass Part Number: 701072780, (CARDIO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2024·2023-12-20

    FDA Recalls Medline Leg Bags for Undeclared Latex

    Medline leg bags contain undeclared latex, creating a risk for users with latex allergies. The company is recalling 28,942 devices distributed in the US and Panama.

    Product
    Medline Leg bag, REF DYND12574
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0661-2024·2023-12-20

    Gaw's Salami & Cheese Bagel recalled for undeclared sesame allergen

    Gaws Gourmet Foods is recalling Gaw's Salami & Cheese Bagel 6oz due to undeclared sesame allergen. Affected products have use-by dates from November 28 through December 15, 2023.

    Product
    Gaw's Salami & Cheese Bagel 6oz, Foam Tray with Clear Plastic Wrap package, UPC:1725600501
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0577-2024·2023-12-20

    Greek Feta Dressing and Related Products Recalled for Temperature Abuse

    Ben E Keith Foods is recalling Greek Feta dressing and other refrigerated and frozen foods shipped in a temperature-abused trailer, affecting 1,721 cases total. No illnesses have been reported.

    Product
    DRESSING GREEK FETA
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0558-2024·2023-12-20

    Ice cream recalled for potential Listeria contamination in 3-gallon containers

    Wilcox Premium Salted Caramel Turtle ice cream (3-gallon) may be contaminated with Listeria monocytogenes. Affected products were distributed in Vermont, New Hampshire, Massachusetts, and New York with best-by dates September 14–November 14, 2024.

    Product
    Wilcox Premium Salted Caramel Turtle in 3 Gallon size
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0581-2024·2023-12-20

    Burn Boot Camp Protein Bars Recalled for Foreign Material Contamination

    Burn Boot Camp AFTERBURN grass-fed whey protein bars (Triple Chocolate with Almond Butter) are being recalled due to foreign material including disposable hairnet, shrink wrap, and parchment paper found in some units. Affected lots are 181, 184, and 187.

    Product
    Burn Boot Camp AFTERBURN GRASS-FED WHEY PROTEN BAR, TRIPLE CHOCOLATE WITH ALMOND BUTTER, NET WT. 2.12 OZ (60 G), packaged in metalized film.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0510-2024·2023-12-20

    Wilcox Premium Coffee Recalled Due to Listeria Contamination

    Wilcox Premium Coffee products with Best By dates from September 14 to November 14, 2024, may be contaminated with Listeria monocytogenes. Products were distributed in Vermont, New Hampshire, Massachusetts, and New York.

    Product
    Wilcox Premium Coffee; 4 oz Cup; UPC 04372600403; Wilcox Premium Coffee in 1.5QT, Quart, Pint, 3 Gallon, and 1 Gallon sizes
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0574-2024·2023-12-20

    Frozen and refrigerated foods recalled due to temperature abuse

    Ben E Keith Foods has recalled 1721 cases of frozen and refrigerated foods that were temperature abused during storage and transit. The temperature-compromised products were distributed to food service operations.

    Product
    LEMON CHOICE MINI PK 34-44 CT; STRAWBERRY SLICED 4-1
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0657-2024·2023-12-20

    Food recall: Gaw's Deluxe Italian sub due to undeclared sesame allergen

    Gaws Gourmet Foods is recalling Gaw's Deluxe Italian sub sandwiches because sesame was not declared on the label. The recalled products were distributed in Michigan.

    Product
    Gaw's Deluxe Italian sub 12oz, Foam Tray with Clear Plastic Wrap package, UPC:1725600910
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0567-2024·2023-12-20

    Sheetz snack mix recalled for undeclared soy allergen

    Sheetz M.T.go! Double Dipped Chocolatey Peanut Butter Peanuts Snax Mix is being recalled because it contains undeclared soy. The product was distributed in North Carolina, Virginia, and West Virginia.

    Product
    Top Label Reads: SHEETZ M.T.go! Made"To"Go DOUBLE DIPPED CHOCOLATEY PEANUT BUTTER PEANUTS SNAX MIX NET WT 6.55 OZ (186 G) Back Panel Reads: SWEET & SPICY SNAX MIX DISTRIBUTED BY SHEETZ DISTRIBUTION SERVICES, LLC. CLAYSBURG, PA 16625 UPC 7 59465 00629 3
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0532-2024·2023-12-20

    Shoulder Implant Recall: RSP Glenoid Baseplate Assembly Defect

    Encore Medical recalls RSP Glenoid Baseplate shoulder implants due to a manufacturing defect in the hex engagement mechanism. The defect could prevent proper installation of the device.

    Product
    RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0525-2024·2023-12-20

    Medline Sterile PVP Solution Recalled Due to Non-Sterile Contents

    Medline Industries is recalling 8,250 units of sterile PVP solution distributed nationwide because the contents are non-sterile despite being labeled as sterile.

    Product
    STERILE PVP SOLUTION, REF DYNDA1907
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2024·2023-12-20

    Iconix Knotless 1.4mm Anchor recalled due to inserter failure risk

    Riverpoint Medical is recalling Iconix Knotless 1.4mm surgical anchors because the inserter can fail or bend when used in hard bone, potentially damaging sutures during insertion or use.

    Product
    Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF 3911-714-521 The Iconix Knotless anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0535-2024·2023-12-20

    Medical Device Recall: Medline Leg Bag with Undeclared Latex

    Medline is recalling 144 Leg bag devices (model REF URO12573) distributed in the US and Panama due to undeclared latex that may cause allergic reactions in sensitive users.

    Product
    Medline Leg bag, REF URO12573
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0531-2024·2023-12-20

    Povidone Solution Labeled Sterile Despite Non-Sterile Contents

    Medline Industries recalls 300 units of Sterile Povidone (REF DYNDA2061) after discovering the solution inside foil sachets is non-sterile despite sterile labeling. Affected lots are distributed across eight states.

    Product
    STERILE POVIDONE, REF DYNDA2061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0551-2024·2023-12-20

    Medical imaging software incorrectly displays patient studies to wrong patients

    Change Healthcare's Stratus Imaging PACS software can incorrectly associate patient imaging studies with the wrong patients. Approximately 454 affected units have been distributed nationwide.

    Product
    Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0521-2024·2023-12-20

    Cardinal Health Stool Transportation System Recalled for Vial Leakage

    Meridian Bioscience is recalling the Cardinal Health Clean Stool Transportation System due to a manufacturing defect that may cause Para-Pak vials to leak. Affected product: 38 cases with Lot Number 510020Q, distributed nationwide and to Italy.

    Product
    Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0523-2024·2023-12-20

    Collision Sensor Malfunction in Siemens ARTIS Icono Fluoroscopic X-Ray System

    The ARTIS icono fluoroscopic x-ray system may falsely detect collisions for up to 30 minutes after startup, requiring manual override with reduced safety protection and limiting diagnostic use.

    Product
    ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0520-2024·2023-12-20

    Medical Device Recall: Para-Pak Zn-PVA Stool Collection Vials for Leakage Risk

    Meridian Bioscience is recalling Para-Pak Zn-PVA stool specimen collection vials due to a manufacturing defect that may cause leakage and risk exposure to biological hazards.

    Product
    Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
    Category
    Medical Device
    Distribution
    Distributed nationwide

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