This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Name: ViziShot 2 FLEX (19G)  Unique Device Identifier (UDI): 00821925043060 Lot Numbers: Full list…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Abiomed has issued a letter…

Catalog Catalog# Description UDI-DI 1000911 t:slim X2 GS, Replacement, Refurbished 00853052007318 1003808 t:slim X2 GS Classic, Replacement, Refurbished 00853052007981 1004219 t:slim X2, Basal-IQ, mg/dl 00853052007998 1004484 Pump, t:slim X2, Clinical Use Only N/A 1005611 Pump, t:slim X2, Control-IQ, mmol/L 00850006613304 1005613 Pump, t:slim X2, Control-IQ, mmol/L, Refurbished Replacement 00850006613311 1005615 Pump, t:slim X2, Control-IQ, mg/dl…

Date Issued: September 16, 2025 The U.S. Food and Drug Administration (FDA) is warning consumers, caregivers, and health care providers of risks related to using unauthorized infant monitors for measuring and monitoring vital signs (such as heart or pulse rate, oxygen saturation, breathing or respiratory rate, and body temperature). Many infant monitors currently sold over-the-counter…

AUDIENCE: Consumer, Health Care Professional, Pediatrics, Family Practice, Neurology ISSUE: The FDA is warning retailers and consumers not to sell or use certain imported cookware that may leach significant levels of lead (Pb) into food. Some types of imported cookware products made from aluminum, brass, and aluminum alloys known as Hindalium/Hindolium or Indalium/Indolium have been…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Abbott has issued a letter…

Date Issued: September 16, 2025 The U.S. Food and Drug Administration (FDA) is warning consumers, patients, caregivers, and health care providers of risks related to using unauthorized devices that claim to measure or estimate blood pressure. Many blood pressure devices currently sold  over-the-counter (OTC) do not have FDA marketing authorization, meaning the FDA has not…

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.  The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Medline has issued a…

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.   Affected Product Product Names: Micro Joystick R-net Multi…

Summary Company Announcement Date: September 12, 2025 FDA Publish Date: September 15, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Pump performance variations compared to the performance described in the user manual could impact infusion delivery Company Name: BD Brand Name: Brand Name(s) Product Description: Product Description BD Alaris Pump Module model…