The tests in a dark blue box have not been authorized, cleared, or approved. The FDA is concerned about the risk of false results when using these tests.

These tests have not been authorized, cleared, or approved. The FDA is concerned about the risk of false results when using these tests.

The tests in a green and white box have not been authorized, cleared, or approved. The FDA is concerned about the risk of false results when using these tests.

Regular clinical follow-up and imaging is critical to detect EVAR device and treatment failures.

FDA reminds the public and health care providers that results from currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person’s level of immunity from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.

Arrow International, LLC is recalling its Arrow-Trerotola Percutaneous Thrombolytic Device due to potential tip damage during use.

Family Dollar,
Inc. is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to 404 stores from Family Dollar Distribution Center 202 in West Memphis, Arkansas from January 1, 2021 through the pre

Baxter International Inc. announced today it has issued an Urgent Safety Communication to reinforce important safety information regarding upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps. Incorrect administration set setup and/or incomplete resolution of upstream occlusi

BASE10 Genetics RNAstill MTM specimen collection kits are being recalled because they are not FDA-authorized, -cleared, or -approved for use.

E25Bio COVID-19 Direct Antigen Rapid Tests are being recalled because they are not authorized, cleared, or approved for use by the FDA.

There is an issue with bellavista 1000 and 1000e ventilators with software version 6.0.1600.0 or higher installed and have the Data Communication port set to “HL7."

Westport, Connecticut, TCP HOT Acquisition LLC dba HRB Brands is voluntarily recalling all lot numbers with expiration dates on or before August 2023 of the Sure and Brut Aerosol Sprays listed in the table below to the consumer level due to the presence of benzene. While benzene is not an ingredient

Wilmington DE, Positive-Health is voluntarily recalling lot number 48658908 with Expiry 9/9/23 of Rise Up Red Edition Capsules packaged in 10-count blisters packaged in a carton to the consumer level. Positive-Health was notified by Amazon that laboratory analysis has found the product to be tainted

Brentwood, NY, Celebrate Today is voluntarily recalling lot number DK1027, Exp 08/01/2023 of Red Mammoth capsules to the consumer level. Celebrate Today was informed by Amazon that laboratory analysis has found the product to be tainted with sildenafil and tadalafil, an ingredients known as a phosph

ABC SALES 1 INC is voluntarily recalling MAC DADDY RED Capsules, Lot 1230004, Exp 03/30/2024 and MAC DADDY PURPLE Capsules, Lot 1230005, Exp 03/30/2024 to the consumer level. ABC Sales 1 Inc was informed by Amazon that laboratory analysis found MAC DADDY RED capsules to be tainted with sildenafil an

The FDA is warning health care providers, parents and caregivers that there is a risk of strangulation in children who use enteral feeding delivery sets.

Your Favorite Shop is voluntarily recalling lot # 26436989. Expiry 10/30/2023 of The Red Pill, packaged in 10-count blisters packaged in a carton to the consumer level. Your Favorite Shop was notified by Amazon that laboratory analysis has found the product to be tainted with tadalafil, an ingredien

In December 2021, imtmedical ag, a subsidiary of Vyaire Medical, initiated a voluntary field correction for certain bellavista™ ventilators. With specific software version and configuration combinations, the ventilators can cease ventilation and generate a technical failure alarm 305. There is a pot

Biosensor, Inc., a global in-vitro diagnostics company, is voluntarily recalling its STANDARD Q COVID-19 Ag Home Test in the United States, due to confirmed reports that the test kits were illegally imported into the United States. The STANDARD Q COVID-19 Ag Home Test is not authorized, cleared or a

Brooklyn, NY Junp LLC is voluntarily recalling Lot number 2010291, Exp Date: 01/07/2024 of MegMan Performance Booster capsules, packaged in 10-count blisters packaged in a carton to the consumer level. Junp LLC was notified by Amazon that laboratory analysis has found the product to be tainted wit