Company: Medtronic, Inc. Date of Enforcement Report: 7/17/2025 Class: II PRODUCT Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 7/17/2025 Class: I PRODUCT Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX Recall Number: Z-2095-2025 REASON: Certain Spectrum infusion pumps may have an incorrect version of software. RECALLING FIRM/MANUFACTURER: Baxter Healthcare Corporation VOLUME: 14 units DISTRIBUTION: US States: CA, FL, IL, KS, MI, MS, NY, OH,...Read More