Max-Lux Safe-T-Lite UV-C WAND may cause injury to the skin, eyes, or both after a few seconds of use.
Recommendations for health care providers due to potential procedural outcome differences between women and men undergoing procedures with LAAO devices.
Eli Lilly and Company (NYSE: LLY) is voluntarily recalling lot D239382D, Expiration April 2022, of Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe), to the consumer/user level. Lilly is recalling lot D239382D to the patient level
Certain canisters of AMBSORB PLUS used to absorb carbon dioxide during anesthesia may cause difficulties in gas flow, resulting in reduced flow to patients.
This catheter is used to visualize and measure parts of the vascular system when used with radiopaque (X-ray detectable) contrast media.
Pipeline Flex Embolization Devices are intended to treat wide-neck and fusiform brain aneurysms. Pieces of the delivery system may break off while in use.
False positives can occur when PCR mixture carries over into nearby assay wells. Letter provides background, recommendations, how to report problems to the FDA.
The FDA is alerting health care providers about the use of certain fluid warmers and the potential for aluminum leaching.
Smiths Medical ASD Inc is recalling the NORMOFLO Irrigation Fluid Warmer and Warmers Sets because of the potential for aluminum ions leaching into warmed fluids.
Level 1? Fast Flow Fluid Warming System, NORMOFLO? Fluid Warmer and Level 1? Normothermic I.V. Fluid Administration Set manufactured by Smiths Medical ASD Inc.
Do not use ultrasound gels and lotions manufactured by Eco-Med, as these products are at risk for bacterial contamination.
FDA is requiring revisions to the Boxed Warning, FDA?s most prominent warning, for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death.
The FDA is alerting patients who had mammograms at Madison Ave Radiology Center on or after February 26, 2019 about possible problems with their mammograms.
NIOSH revoked all respirator approvals previously issued to Shanghai Dasheng
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.
Monoject Saline Prefilled Flush Syringes recalled. Syringe plungers may let air back into the syringe, leading to air embolism
Cardinal Health recalls the Argyle Umbilical Venous Catheter Insertion Tray due to missing instructions for use for the included Safety Scalpel N11.
FDA reminds patients and healthcare providers the safety and effectiveness of RAS devices in mastectomy or breast cancer treatment has not been established
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
Ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination.
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
When used for warming therapy, the Recirculator 8.0 Disposable Lavage Kit from Eight Medical may expose patients to high levels of aluminum.
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
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.
Eco-Med Pharmaceuticals, Inc. today commenced a voluntary recall of certain lots of its Eco-Gel 200 ultrasound gel due to bacterial contamination. The product is also distributed as MediChoice Ultrasound Gel by Owens and Minor and Mac Medical Supply. These ultrasound gels are non-sterile and not