Summary Company Announcement Date: February 25, 2025 FDA Publish Date: February 25, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination of the product with Staphylococcus aureus (S. aureus) Company Name: Ascent Consumer Products Inc. Brand Name: Brand Name(s) SinuCleanse Product Description: Product Description Soft Tip Squeeze Bottle Nasal Wash System Company…
Pacemaker Recall: Boston Scientific Corporation Recalls Accolade Pacemaker Devices Due to a Manufacturing Issue That May Lead to Early Device Replacement
This recall involves the potential need for device explant. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the What to Do section below. Affected Product Product Names: ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR)…
Kayco Issues an Allergy Alert on Undeclared Milk in Limited Units of Glicks Dark Chocolate Conettos
Summary Company Announcement Date: February 21, 2025 FDA Publish Date: February 21, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared milk allergen Company Name: Kayco Brand Name: Brand Name(s) Product Description: Product Description Dark Chocolate Conettos Company Announcement Bayonne, NJ. (February 21st, 2025) – Kayco, a Bayonne NJ company…
One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalafil
Summary Company Announcement Date: February 20, 2025 FDA Publish Date: February 20, 2025 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Tadalafil Company Name: One Source Nutrition Brand Name: Brand Name(s) Product Description: Product Description Vitality male enhancement dietary supplement capsules Company Announcement FOR IMMEDIATE RELEASE – Benton, Arkansas –…
Kedake Inc. Issues Allergy Alert on Undeclared Sesame, Soy, Wheat, Yellow No. 5, Yellow No. 6, and Red No. 6 in Botana Mix Snacks
Summary Company Announcement Date: February 20, 2025 FDA Publish Date: February 20, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared wheat, sesame, soy, yellow 5, yellow 6, red 6 Company Name: Kedake Inc Brand Name: Brand Name(s) Product Description: Product Description Las Ollas Botana Mix Snacks and Delights 2…
ZB Importing Issue Voluntary Recall and Allergy Alert on Undeclared Egg, Wheat and Milk in Certain Ulker Brand Products
Summary Company Announcement Date: February 18, 2025 FDA Publish Date: February 20, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared allergen (wheat, eggs, milk) Company Name: ZB Importing LLC Brand Name: Brand Name(s) Product Description: Product Description Snack rolls, biscuits, and wafers Company Announcement ZB Importing LLC is voluntarily…
Naturipe Value Added Fresh LLC Issues Allergy Alert On Undeclared Wheat & Eggs In “Berry Buddies, Berries & Pancakes” Lot # 1097901
Summary Company Announcement Date: February 18, 2025 FDA Publish Date: February 19, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared allergen (wheat, eggs) Company Name: Naturipe Value Added Fresh LLC Brand Name: Brand Name(s) Naturipe Snacks Product Description: Product Description Berry Buddies, Berries & Pancakes bento box snack packs…
BD Announces Voluntary Worldwide Recall for One Lot of ChloraPrep™ Clear 1 mL Applicators Due to Fungal Contamination
Summary Company Announcement Date: February 15, 2025 FDA Publish Date: February 18, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential for fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides Company Name: BD Brand Name: Brand Name(s) Product Description: Product Description ChloraPrep Clear 1 mL applicator skin preparation product…
Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion, Adjustment, Or Removal
This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions. Affected Product Product…
Mauna Loa Macadamia Nut Company, LLC Issues a Product Recall on Undeclared Almonds in Mauna Loa Milk Chocolate Covered Macadamias (1oz) Pouches
Summary Company Announcement Date: February 15, 2025 FDA Publish Date: February 15, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared almonds Company Name: Mauna Loa Macadamia Nut Company, LLC Brand Name: Brand Name(s) Product Description: Product Description Mauna Loa Milk Chocolate Covered Macadamias Company Announcement February 15, 2025, Mauna Loa…