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Showing 3881–3900 of 68218 results

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LITE Regener-Eyes Solution (Regenerative Processing) – Sterility Issue (2024)

Lack of Sterility Assurance

Class IIModerate

FDADec 10, 2024Nationwide• Regenerative Processing Plant, LLC

Idylla Instrument (Biocartis) – False-Positive MSI-H Results (2024)

False-positive MSI-H results generated by the Idylla MSI Test.

Moderate

FDADec 10, 2024AL, CA, NJ +2 more• Biocartis Nv B 3 Generaal De Wittelaan 11 Mechelen Belgium

Cappuccino Meltaway Bar (Gardner's Candies) – undeclared tree nuts (2024)

Undeclared Allergen

Product contains Undeclared Allergen Tree Nuts (Cashews)

Class IHigh

FDADec 10, 2024CA, FL, GA +8 more• GARDNER'S CANDIES , INC

Regener-Eyes Ophthalmic Solution (Regenerative Processing) – Sterility Risk (2024)

Lack of Sterility Assurance

Class IIModerate

FDADec 10, 2024Nationwide• Regenerative Processing Plant, LLC

Baker's Source Cornbread Mix (C.H. Guenther) – undeclared egg (2024)

Undeclared Allergen

Undeclared egg allergen

Class IHigh

FDADec 10, 2024AR, FL, LA +5 more• C.H. Guenther & Son, Inc.

VasoView HemoPro 2 Vessel Harvesting System (Maquet) – Multiple Component Risks (2024)

Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

Moderate

FDADec 9, 2024Nationwide• Maquet Cardiovascular, LLC

JMC5A Oxygen Concentrator (Jiangsu Jumao) – Fire Hazard Risk (2024)

Fire/Burn Risk

Oxygen concentrator may melt or catch on fire during use.

High

FDADec 9, 2024OH• JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD No

VasoView Hemopro 2 with Vasoshield (Maquet) – Multiple Component Risks (2024)

Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

Moderate

FDADec 9, 2024Nationwide• Maquet Cardiovascular, LLC

MadeGood Chocolate Chip Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Chocolate Chip Granola Mini Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Strawberry Granola Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Mixed Berry Granola Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Chocolate Banana Granola Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Bloody Mary Mix (Borsari) – undeclared fish and soy (2024)

Undeclared Allergen

Product contains undeclared fish (anchovy) and soy.

Class IIModerate

FDADec 9, 2024AL, AZ, CA +22 more• Borsari Food Company Inc

Made Good Variety Pack (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Cookies & Creme Granola Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Chocolate Drizzled Birthday Cake Granola Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Chocolate Drizzled Cookie Crumble Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Chocolate Drizzled Vanilla Granola Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

Halloween Chocolate Chip Mini Bars (Riverside) – metal pieces (2024)

may contain metal pieces

Class IIModerate

FDADec 9, 2024Nationwide• Riverside Natural Foods, Ltd.

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