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Showing 3981–4000 of 11714 results

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Access TSH Assay (Beckman Coulter) – Erroneously Low Results (2024)

Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.

FDAAug 28, 2024Nationwide• Beckman Coulter, Inc.

Barrier Therapy Skin Cream (PreQuel) – Microbial Contamination (2024)

Microbial contamination of non-sterile Products -

Class IIModerate

FDAAug 28, 2024Nationwide• PREQUEL SKIN

Chocolate Milk (Big Bottom) - Pasteurization Issue (2024)

Required pasteurization temperatures were not achieved.

Class IIModerate

FDAAug 28, 2024GA, NC, SC• Big Bottom Milk Company

Medline Open Heart Pack (MEDLINE) – Cannulae Component Risk (2024)

Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.

FDAAug 28, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Medline Heart Overhead Table Pack (MEDLINE) – Cannulae Component Risk (2024)

FDAAug 28, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Chocolate Milk (Big Bottom) - Pasteurization Issue (2024)

Required pasteurization temperatures were not achieved.

Class IIModerate

FDAAug 28, 2024GA, NC, SC• Big Bottom Milk Company

Chocolate Milk (Big Bottom) - Pasteurization Issue (2024)

Required pasteurization temperatures were not achieved.

Class IIModerate

FDAAug 28, 2024GA, NC, SC• Big Bottom Milk Company

HAWK Warming Grid (Safeguard) – Incorrect Expiration (2024)

Incorrect expiration date.

FDAAug 27, 2024Nationwide• Safeguard US Operating LLC

HAWK Hypothermia Set (Safeguard) – Incorrect Expiration (2024)

Incorrect expiration date.

FDAAug 27, 2024Nationwide• Safeguard US Operating LLC

Convenience Kits (Safeguard) – Incorrect Expiration (2024)

Incorrect expiration date.

FDAAug 27, 2024Nationwide• Safeguard US Operating LLC

Raisin Bran Muffin (Posh Bakery) - Undeclared Allergens (2024)

Undeclared Allergen

Undeclared whey (milk), wheat flour, & bran (wheat); no nutrition fact panel & no contains statement

Class IHigh

FDAAug 27, 2024Nationwide• The Posh Bakery, Inc.

Blueberry Muffin (Posh Bakery) - Undeclared Allergens (2024)

Undeclared Allergen

Undeclared whey (milk) & wheat flour: no nutrition fact panel & no contains statement

Class IIModerate

FDAAug 27, 2024Nationwide• The Posh Bakery, Inc.

Apple Cinnamon Muffin (Posh Bakery) - Undeclared Allergens (2024)

Undeclared Allergen

Undeclared whey (milk) & wheat flour: no nutrition fact panel & no contains statement

Class IIModerate

FDAAug 27, 2024Nationwide• The Posh Bakery, Inc.

Cranberry Muffin (Posh Bakery) - Undeclared Allergens (2024)

Undeclared Allergen

Undeclared whey (milk) & wheat flour; no nutrition fact panel & no contains statement

Class IIModerate

FDAAug 27, 2024Nationwide• The Posh Bakery, Inc.

Lemon Muffin (Posh Bakery) - Undeclared Allergens (2024)

Undeclared Allergen

Undeclared whey (milk) & wheat flour; no nutrition fact panel & no contains statement

Class IIModerate

FDAAug 27, 2024Nationwide• The Posh Bakery, Inc.

Poppy Seed Muffin (Posh Bakery) - Undeclared Allergens (2024)

Undeclared Allergen

Undeclared whey (milk), wheat flour, almonds; no contains statement & no nutrition fact panel

Class IIModerate

FDAAug 27, 2024Nationwide• The Posh Bakery, Inc.

Banana Nut Muffin (Posh Bakery) - Undeclared Allergens (2024)

Undeclared Allergen

Undeclared whey (milk) and wheat flour; no nutritional fact panel & no contains statement

Class IIModerate

FDAAug 27, 2024Nationwide• The Posh Bakery, Inc.

Carrot Muffin (Posh Bakery) - Multiple Allergens (2024)

Undeclared Allergen

Undeclared whey (milk), wheat flour, & coconut; no nutrition fact panel & no contains statement

Class IIModerate

FDAAug 27, 2024Nationwide• The Posh Bakery, Inc.

Chocolate Chip Muffin (Posh Bakery) - Undeclared Allergens (2024)

Undeclared Allergen

Undeclared whey (milk) & wheat flour; no nutrition fact panel & no contains statement

Class IIModerate

FDAAug 27, 2024Nationwide• The Posh Bakery, Inc.

FastPack TSH Calibrator (Qualigen) – Barcode Mismatch (2024)

Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected.

FDAAug 26, 2024AL, AK, GA +22 more• Qualigen Inc

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