1,264 recalls tagged with “fda regulated”.
Surepulse Medical recalled the Extra Large VS Cap component of its newborn heart rate monitor on January 20, 2023. The recall followed reports of incorrect sizing information that could impact device use. This recall affects distribution in the U.S., the U.K., the Netherlands, and the United Arab Emirates.
Surepulse Medical recalled the VS Cap Small component of its newborn heart rate monitor on January 20, 2023. The recall stems from incorrect sizing information provided on the product label. This defect poses a significant risk to patient safety.
Foundation Medicine issued a recall affecting 18 FoundationOne Liquid CDx tests, including 17 in the United States and 1 overseas. The defect is the absence of the companion diagnostic CDx Claims Page in reports. Amended claims pages were distributed within seven days. Stop use immediately and follow manufacturer instructions.
Foundation Medicine recalled 59 units of FoundationOne CDx (F1CDx), RAL-0003 version 31.0 after reports indicated the companion diagnostic Claims Page was omitted. This oversight could impact patient care and healthcare provider decisions concerning diagnosis and treatment. Users should stop using the device and contact Foundation Medicine or their healthcare provider for further instructions.