This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves correcting 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…
Early Alert: Infusion Pump Issue from Baxter Healthcare Corporation
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…
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…
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,…
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…
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)…
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 –…