Summary Company Announcement Date: February 25, 2025 FDA Publish Date: February 26, 2025 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil Company Name: Natural Dior LLC Brand Name: Brand Name(s) Natural Dior LLC Product Description: Product Description Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – Natural Dior LLC (USA) – February…
Patient Table Correction: Philips Updates Use Instructions for Allura and Azurion Systems due to Patient Fall Risk from Incorrectly Positioned Mattresses
This recall involves updating instructions for using 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 …
Ablation Catheter Correction: Biosense Webster Updates Use Instructions for Varipulse due to High Rate of Stroke or Transient Ischemic Attack
This recall involves updating the Instructions for using these 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…
Update on Alert: Solution Set Issue from Baxter Healthcare Corporation
This communication was initially issued as part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. This recall involves removing certain devices from where they are used or sold. The affected products and recommendations…
Update on Alert: Infusion Pump Software Issue from Fresenius Kabi USA
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,…