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As of December 2, 2022, Getinge Maquet/Datascope Intra-Aortic Balloon Bump (IABP) devices were added to the FDA’s medical device shortage list as officials worked to inform healthcare facilities and providers. The shortage, first called to attention by Getinge on November 29, 2022, points to “limited […]

As a public service, the FDA is calling to attention a voluntary nationwide recall of select lots of sodium bicarbonate injection produced by Excela Pharma Sciences, LLC. The company announcement, made on October 12, 2022, and posted to the FDA’s website on October 13, 2022, […]

As of November 1, 2002, the FDA has updated its recommended uses and required labeling of authorized COVID-19 antigen tests as a measure against possible false negative results. This new guidance emphasizes repeat testing, or serial testing, over a prolonged period in an effort to […]

Pennsylvania-based medical technologies provider, Teleflex Inc., recalled over 60,000 respirator filters after receiving dozens of reports that they were splitting or detaching while in use. The worldwide recall, announced in late August, includes lots of the Gibeck® Iso-Gard® Filter products manufactured between December 17, 2019, […]

The FDA is looking into the correlation between the use of osteoporosis medication Prolia and severe hypocalcemia in patients treating their advanced kidney disease with dialysis. . Prolia, initially approved in 2010 as a treatment of postmenopausal women with osteoporosis. The medication was later approved […]

The FDA recently warned parents, caregivers, and healthcare providers about using infant head-shaping pillows that claim to treat or prevent medical conditions. The pillows are made with a small indent, so when the child is laid on their back, it cradles the back of their […]

Baxter Hillrom is recalling their Incontinence Management System after reports that the radiofrequency emissions form the device could interfere with other vital medical equipment. The WatchCare Incontinence Management System (IMS) is designed to detect moisture through Centrella, Progressa, and VersaCare hospital beds and disposable incontinence […]

Boston-based Whele, LLC voluntarily recalled more than 500,000 of their Mighty Bliss Electric Heating Pad units after receiving numerous product safety concerns from consumers. The recall was announced on October 28th, 2022, and applies to units manufactured from Jan. 2021 – Jan. 2022 that were […]

The FDA recently requested additional details on a number of Philips Respironics Trilogy Ventilators that are experiencing new potential issues after they were reworked as part of a June 2021 recall. The initial recall involved millions of ventilator and sleep apnea devices with defects that […]

After three recalls by the U.S. Food and Drug Administration (FDA) and the shuttering of its facility, Florida pharmaceutical company PharmaTech LLC is now the subject of seven stool softener lawsuits, several involving the death of an infant. Diocto Liquid PharmaTech LLC, the maker of […]

The U.S. Food and Drug Administration (FDA) approved Xeljanz and Xeljanz XR on November 6, 2012, and February 23, 2016, respectively. Both drugs are made by Pfizer, Inc. and were approved to treat moderate to severe active rheumatoid arthritis. Rheumatoid arthritis (RA) is the most […]

The U.S. Food and Drug Administration (FDA) approved Ocaliva (obeticholic acid) on May 31, 2016, to treat primary biliary cholangitis (PBC), a chronic liver condition resulting from destruction of the bile ducts in the liver. When the bile ducts are impaired, bile builds up in […]