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Medicine Recalls

Max-Lux Safe-T-Lite UV-C WAND may cause injury to the skin, eyes, or both after a few seconds of use. 9/29/2021

Recommendations for health care providers due to potential procedural outcome differences between women and men undergoing procedures with LAAO devices. 9/27/2021

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 9/26/2021

Certain canisters of AMBSORB PLUS used to absorb carbon dioxide during anesthesia may cause difficulties in gas flow, resulting in reduced flow to patients. 9/23/2021

This catheter is used to visualize and measure parts of the vascular system when used with radiopaque (X-ray detectable) contrast media. 9/22/2021

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. 9/20/2021

False positives can occur when PCR mixture carries over into nearby assay wells. Letter provides background, recommendations, how to report problems to the FDA. 9/17/2021

The FDA is alerting health care providers about the use of certain fluid warmers and the potential for aluminum leaching. 9/15/2021

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. 9/15/2021

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. 9/15/2021

Do not use ultrasound gels and lotions manufactured by Eco-Med, as these products are at risk for bacterial contamination. 9/10/2021

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. 9/1/2021

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. 8/26/2021

NIOSH revoked all respirator approvals previously issued to Shanghai Dasheng 8/25/2021

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. 8/24/2021

Monoject Saline Prefilled Flush Syringes recalled. Syringe plungers may let air back into the syringe, leading to air embolism 8/23/2021

Cardinal Health recalls the Argyle Umbilical Venous Catheter Insertion Tray due to missing instructions for use for the included Safety Scalpel N11. 8/20/2021

FDA reminds patients and healthcare providers the safety and effectiveness of RAS devices in mastectomy or breast cancer treatment has not been established 8/20/2021

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 8/20/2021

Ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination. 8/18/2021

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 8/12/2021

When used for warming therapy, the Recirculator 8.0 Disposable Lavage Kit from Eight Medical may expose patients to high levels of aluminum. 8/12/2021

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 8/12/2021

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. 8/10/2021

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 8/4/2021