The FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines to address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants.

SD BioSensor is recalling some Pilot COVID-19 At-Home Tests for the risk that a bacteria contamination could harm users or cause false test results.

Draeger Seattle PAP Plus and some breathing circuit or anesthesia kits may have parts that loosen or detach, preventing needed breathing support.

Replacement batteries for ICU Medical’s Plum 360, Plum A+ and Plum A+3 large volume infusion pumps may have shorter than expected battery life.

San Juan, PR, Novis PR LLC is voluntarily recalling Lot D20911 Exp 10/25 of G-Supress DX Pediatric Drops to the consumer level. Some cartons of the product have been found to contain incorrect product inside. Incorrect product inside is an anesthetic/analgesic and not a brand of Novis PR LLC.

San Juan, PR, Novis PR LLC está retirando voluntariamente el lote D20911 Exp 10/25 de gotas pediátricas G-Supress DX a nivel de consumidor. Se ha encontrado que algunas cajas del producto contienen un producto incorrecto en su interior. El producto incorrecto en el interior es un anestésico/analgési

New labeling for AFX2 Endovascular AAA System (AFX2) includes information to better inform patients and health care providers of the risk of Type III endoleaks

BearCare, Inc. is initiating a voluntary recall of its rechargeable Walnut Wearable Smart Thermometer (Walnut Thermometer) due to reports of injuries, including skin burns, by users. The Walnut Thermometer is an over-the-counter rechargeable device intended for continuous chest temperature monitorin

Renuvion/J-Plasma device can be used for additional aesthetic skin procedures

SD Biosensor, Inc. today is requesting that consumers stop using and dispose of specific Pilot COVID-19 At-Home Tests in the United States because potentially harmful bacteria were found in the tube with liquid inside (pouch 2 of the kits). The affected tests can be identified by the lot number on

Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test.

UV wands may cause injury to the skin, eyes, or both after a few seconds of use.

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

Gurnee, IL, Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The Akorn Trustee is initiating a voluntary recall of various w

Family Dollar is initiating a voluntary retail level product recall of certain over-the-counter drug products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to certain stores on or around June 1, 2022 through March 31, 2023 due to product being stored by Family

Teva Pharmaceuticals USA, has initiated a voluntary nationwide recall of specific lots of various strengths of FENTANYL Buccal Tablets CII to the Consumer Level. Teva USA manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne’s label. This recall has been initiated

Illumina cybersecurity vulnerability affecting the Universal Copy Service software may impact patient health results.

West Sacramento, CA, Gear Isle is voluntarily recalling the following products listed in the table below to the consumer level. FDA analysis has found the products to be tainted with sildenafil and tadalafil. Sildenafil and tadalafil are ingredients known as Phosphodiesterase Inhibitors (PDE-5) inhi

Gurnee, IL, Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The Akorn Trustee is initiating a voluntary recall of various w

2023 Medical Device Recalls