The FDA is alerting patients who had mammograms at Capitol Radiology, LLC in Laurel, Maryland, on or after June 26, 2018, about possible problems with the quality of their mammograms.

Medline Industries recalled Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, which is used for inhalation and irrigation therapy. The saline solution was found to be non-sterile.

The Abbott Proclaim and Infinity neurostimulation systems deliver low-intensity electrical impulses to nerve structures. The device may be unable to exit MRI mode and resume therapy.

FDA is working closely with the CDC to investigate recent reports of a TB outbreak caused by Mycobacterium tuberculosis (Mtb) that appears to be linked to a bone matrix product.

The One-Way Valve, 22F x 22M is a single-use device accessory used to prevent backward flow of nitric oxide gas into the airways.

Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune for

FOR IMMEDIATE RELEASE – September 13, 2023 – EWING, N.J – Church & Dwight Co., Inc. (NYSE:CHD) today initiated a voluntary recall of one specific lot of TheraBreath Strawberry Splash for Kids 16oz after the Company identified a microbial contamination due to the presence of yeast (Candida Parapsilo

FOR IMMEDIATE RELEASE – September 8, 2023 – EWING, N.J – Church & Dwight Co., Inc. (NYSE:CHD) today initiated a voluntary recall of one specific lot of TheraBreath Kids Strawberry Splash 16oz after the
Company identified a microbial contamination due to the presence of yeast (Candida Parapsilosis)

Certain surgical respirators, surgical masks, and pediatric face masks by O&M Halyard do not meet quality and performance expectations.

Brooklyn, New York, WEFUN Inc is voluntarily recalling 300 Boxes of WEFUN Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) inhibitor found in FDA-approved products for the trea

Brooklyn, New York, WEFUN Inc is voluntarily recalling 300 Boxes of WEFUN Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) inhibitor found in FDA-approved products for the trea

Listing of Medical Device 2023 Safety Communications

Cardiosave IABPs are used to inflate and deflate intra-aortic balloons. The device may stop unexpectedly due to Autofill Failure Alarms and will be put in standby mode.

Cardiosave IABPs are used to inflate and deflate intra-aortic balloons. If they become unseated from the hospital cart, they can shut down without warning.

The FDA is alerting health care facilities and providers of a shortage of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including limited supplies of IAB catheters, new Cardiosave IABPs, and Cardiosave IABP parts.

The Cardiosave IABP may stop unexpectedly due to a high priority Gas Gain or Gas Loss alarm. The alarm will interrupt therapy and require user intervention to correct and restart.

New Castle, Delaware, Marlex Pharmaceuticals, Inc. is voluntarily recalling one lot of Digoxin Tablets USP, 0.125mg and one lot of Digoxin Tablets USP, 0.25mg to the consumer level due to Label Mix-Up. Bottles of Digoxin Tablets, USP 0.125mg s are incorrectly labeled and contain Digoxin Tablets USP,

Cardiosave IABP devices may unexpectedly shutdown or interrupt therapy (pump stops).

The Cardiosave IABP may stop unexpectedly when internal temperatures exceed 176 degrees Fahrenheit.

On July 1, 2023, Universal Meditech Inc. initiated a nationwide recall of products it manufactured between March 2021 and November 2022. The recall is due to the reasons that: i.The company is going out of business, hence would not be able to continue fulfilling any post-market responsibilities of