The FDA is updating our October 28, 2019 safety communication on the use of AFX endovascular grafts with Duraply material (AFX with Duraply or AFX2).

NIOSH revoked all respirator approvals previously issued to Shanghai Dasheng

List of Medical Device recalls in 2021.

Bezel posts on the Alaris Infusion Pump Module 8100 are critical to pump function. Bio-Medical Equipment Service Co. bezel posts may crack or separate.

Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for all Spectrum IQ infusion pumps to reinforce important safety information when customers implement changes to their network configuration and server systems. Baxter previously communicated this informatio

Monoject Saline Prefilled Flush Syringes recalled. Syringe plungers may let air back into the syringe, leading to air embolism

On August 4, 2021, Cardinal Health (NYSE: CAH) initiated a nationwide recall of approximately 267 million MonojectTM Flush Prefilled Saline Syringes (0.9% Sodium Chloride). The products have been found to reintroduce air into the syringe after the air has been expelled. This could result in injectio

FDA reminds patients and healthcare providers the safety and effectiveness of RAS devices in mastectomy or breast cancer treatment has not been established

Cardinal Health recalls the Argyle Umbilical Venous Catheter Insertion Tray due to missing instructions for use for the included Safety Scalpel N11.

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

Ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination.

Ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination.

Pfizer is voluntarily recalling an additional four lots of Chantix 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

Increased risk of neurological adverse events, mortality and possible failure of the pump to restart led to stop sale and distribution of HeartWare HVAD System

Medtronic has stopped the sale and distribution of HVAD because the internal pump may delay or fail to restart.

A software defect in Baxter’s Dose IQ Software version 9.0.x may impact how fluid is delivered to a patient with the Spectrum IQ Infusion Pump

[eBay Seller ID: jongu 4308] is voluntarily recalling all lots of Hydro Pineapple Burn to consumer level. FDA analysis has found the product to contain undeclared sibutramine. Sibutramine was an FDA approved drug used as an appetite suppressant for weight loss but was withdrawn from the market beca

SterRx, LLC today announced the voluntary nationwide recall of three lots of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL due to waterborne microbial contamination. SterRx, LLC has initiated this voluntary recall of Sodium Bicarbonate injection, to the Hospital Pharmacy level.

Boston Scientific recalls INGENIO Family of Pacemakers and CRT-Ps, used to treat slower than normal heartbeats and heart failure, due to the risk of transitioning to safety mode.

Boston Scientific recalls INGENIO Family of Pacemakers and CRT-Ps, used to treat slower than normal heartbeats and heart failure, due to the risk of incorrect transition to safety mode.