FDA Warning & Recall Information

A recall of Baxter Healthcare Corporation’s Clearlink Basic Solution Set with Duovent, initiated by the firm on August 9, 2022, has been labeled by the FDA as Class I, the most serious type. This designation indicates that use of the product may lead to serious […]

An October 17, 2022 recall of the Arrow AutoCAT 2 and AC3 Intra-Aortic Balloon Pumps by Arrow International, LLC (a subsidiary of Teleflex) has been identified by the FDA as Class I, the most serious category.  The action affects products sold under 12 different names, […]

Due to a risk of serious injuries or death, the FDA has identified a Class I recall of the Arrow MAC Two-Lumen Central Venous Access Kits and the Pressure Injectable Arrowg+ard Blue Plus Three Lumen Central Venous Catheter (CVC) Kits by Teleflex and Arrow International, […]

Two lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg by Aurobindo Pharma USA, Inc. were put under voluntary recall, according to an October 24, 2022 press release. The manufacturer listed “Nitrosamine Drug Substance Related Impurity” (NDSRI) as the reason behind the action after N-Nitroso-Quinapril was […]

In a major mass litigation, 14,000 claims have been filed after the Camp Lejeune Justice Act was passed into law this past August. The new law allows Marines and their families to sue the U.S. government for harm traced to exposure to contaminated water while […]

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 […]