FDA Warning & Recall Information

In a letter posted to its site on October 7, 2020, the FDA asked healthcare providers to institute a set of precise instructions to patients collecting their anterior nares (nasal) sample in a healthcare setting for SARS-CoV-2 testing. The agency outlined its recommendations out of […]

The FDA continues to ensure healthcare providers are aware of an urgent recall of the JET 7 Reperfusion Catheter with Xtra Flex Technology (also known as JET 7 Xtra Flex) by Penumbra. Penumbra voluntarily recalled the product in all its configurations on December 15, 2020, […]

Three lots of Detect Covid-19 Tests by Detect, Inc. have been voluntarily recalled; the FDA announced on its site Monday, December 12, 2022. The firm communicated the recall four days prior and it was initiated after an internal investigation revealed that tests in the lots […]

Following an October 25, 2022 Urgent Medical Device Correction issued by Remel, Inc, the FDA has identified a Class I recall of the firm’s Thermo Scientific Gram Negative IVD AST Sensititre Plate. Used exclusively “by trained laboratory personnel,” the device tests “the susceptibility of Gram-negative […]

The FDA is calling to attention the Class I recall of DNA/RNA Preservation Kits by Dewei Medical Equipment Co. The recall, initiated by the firm on August 19, 2022, came after the products were found to have been distributed to U.S. customers without FDA authorization, […]

On November 7, 2022, the FDA alerted the public of a voluntary recall of 20 lots of Adam’s Polishes Hand Sanitizer after FDA testing detected undeclared methanol in a single lot. In an announcement posted to its site, the company said it recalled the additional […]

On November 4, 2022, the FDA alerted the public to a Medical Device Correction announced on October 17, 2022, by Insulet Corporation regarding all of the company’s Omnipod DASH Person Diabetes Managers (PDMs). The action was made after Insulet had fielded 50 reports from Omnipod […]

On September 8, 2022, the FDA warned healthcare providers of possible clip-lock malfunctions posed by the Abbott MitraClip Clip Delivery Systems. The alert was sent out in parallel with the company’s communication dated the same day. A heart valve repair device designed to treat mitral […]

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, […]