This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product Sigma Spectrum Infusion System Spectrum IQ Infusion System The FDA…
U.S. Trading Company of Hayward, CA is Recalling Joy Luck Brand Lily Flowers Because it May Contain Undeclared Sulfites
Summary Company Announcement Date: March 04, 2025 FDA Publish Date: March 04, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared sulfites Company Name: U.S. Trading Company Brand Name: Brand Name(s) Product Description: Product Description Dried Lily Flowers Company Announcement (March 3, 2025) U.S. Trading Company of Hayward, CA is…
Endovascular System Recall: Philips Removes and Discontinues Distribution of Tack Endovascular System Due to User Challenges That Caused Additional Procedures to Reposition or Remove Implant
This recall involves removing 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: Tack Endovascular System (4F,1.5-4.5mm), 150cm Tack Endovascular System (6F, 3.5 – 6.0mm), 135c Tack…
AKT Trading Inc. Recalls Prepared Vegetable Products Because of Possible Health Risk
Summary Company Announcement Date: March 03, 2025 FDA Publish Date: March 03, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential risk of Clostridium botulinum Company Name: AKT Trading, Inc. Brand Name: Brand Name(s) Multiple brands Product Description: Product Description Prepared vegetable products. Company Announcement AKT Trading Inc. of…
Vaporizer Recall: Getinge Removes Vaporizer Sevoflurane Quick-Fil and Expands Recall of Vaporizer Sevoflurane Maquet Filling due to Risk of Patient and Health Care Professional Exposure to Toxic Chemical Hydrogen Fluoride
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,…