This recall involves removing certain devices 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. This is an expansion of the 2024 Class I Recall: Getinge Recalls Vaporizer Sevoflurane Maquet Filling for…
Endoscope Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due to Risk for Radiopaque Guide Sheath Tip Detaching During Procedures
This recall involves removing certain devices 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. Affected Product Product Names: Single Use Guide Sheath Kits: K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps,…
Little Leaf Farms Announces Limited Voluntary Withdrawal of a Specific Lot Code of Southwest Salad Kit Due to Undeclared Fish and Wheat
Summary Company Announcement Date: February 28, 2025 FDA Publish Date: March 01, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared fish and wheat allergen Company Name: Little Leaf Farms Brand Name: Brand Name(s) Little Leaf Farms Product Description: Product Description Southwest Salad Kits Company Announcement Little Leaf Farms is voluntarily…
Regard Newborn Kit Recall: ROi CPS, LLC Removes Certain Newborn Kits Due to a Recalled Component, the Neo-Tee T-Piece Resuscitator With An Undersized Controller Spring
This recall involves removing certain devices 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. Affected Product Product Name: Regard Newborn Kit Lot number 104006, Exp. 9/30/2026, UDI (01)10194717119074(17)260930(10)104006 Lot number 103486,…
Power Assist Device Recall: Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+ Power Assist Device Due to Risk for Motor to Be Unresponsive to the User
This recall involves removing certain devices 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. Affected Product Product Name: Speed Control Dial Component Used with the SmartDrive MX2+ Power Assist Device Part…
Lyons Magnus Recalls Lyons ReadyCare and Sysco Imperial Frozen Supplemental Shakes Manufactured by Third Party Because of Possible Health Risk
Summary Company Announcement Date: February 22, 2025 FDA Publish Date: February 23, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Possible Listeria monocytogenes contamination Company Name: Lyons Magnus LLC Brand Name: Brand Name(s) ReadyCare, Imperial Product Description: Product Description Frozen supplemental shakes Company Announcement FRESNO, Calif. – February 22,…
Ascent Consumer Products Inc. Issues Voluntary Nationwide Recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System Due to Microbial Contamination
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 –…