MedWatch Safety Alerts

Disruptions in Availability of Hemodialysis Bloodlines - Letter to Health Care Providers

The FDA is adding hemodialysis bloodlines (also referred to as set, tubing, blood, with and without anti-regurgitation valve; product code FJK) to the Medical Device Shortage List

2024 Letters to Health Care Providers

The FDA posts letters to health care providers about the safe use of medical devices

Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., Due to Mislabeling of Infusion Bag

Dr. Reddy’s Laboratories Ltd is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to

Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC): Voluntary Lot Withdrawals - Due to Increased Reports of Allergic/Hypersensitivity Reactions

As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers

Smiths Medical Issues Urgent Medical Device Correction Informing Customers of a Potential Issue with Certain Sizes of Intubation ORAL/NASAL Endotracheal Tubes Being Smaller Than Expected

Smiths Medical has issued an Urgent Medical Device Correction to notify affected global customers of a potential issue with the 2.0, 2.5, 3.0 and 3.5 mm sizes of Intubation ORAL/

Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication

The FDA is raising awareness about cybersecurity vulnerabilities with Contec CMS8000 and Epsimed MN-120 patient monitors

Update on Alert: Solution Set Issue from Baxter Healthcare Corporation

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Update on Alert: Fluid Delivery Set Issue from Medline

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Update on Alert: Infusion Pump Issue from Fresenius Kabi USA

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Update on Alert: Nephroscope Sheath Issue from Trokamed GmbH

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Early Alert: Infusion Pump Issue from Baxter Healthcare Corporation

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Update on Alert: Extracorporeal Blood Circuit Issue from Nuwellis

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

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

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

Vaporizers Sevoflurane Quick-Fil and Maquet Filling mix oxygen and sevoflurane for anesthesia. This sevoflurane may degrade to toxic hydrogen fluoride

One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalafil

One Source Nutrition is voluntarily recalling all lots of Vitality capsules to the Consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil

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

Tack Endovascular System is used to repair artery dissection after angioplasty but ongoing user issues led Philips to discontinue use and distribution

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

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial used with SmartDrive MX2+ Wheelchair Power Assist system may be unresponsive to users

Pacemaker Recall: Boston Scientific Corporation Recalls Accolade Pacemaker Devices Due to a Manufacturing Issue That May Lead to Early Device Replacement

Boston Scientific is recalling pacemakers due to a manufacturing issue that may cause early device replacement

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

ROi newborn kits include Neo-Tee T-Piece Resuscitators. The Neo-Tee may have an undersized controller spring that could affect patient breathing support