Company: Beckman Coulter, Inc Date of Enforcement Report: 2/2/2026 Class: II PRODUCT: CellMek SPS Sample Preparation System, REF: C44603, with software Recall Number: Z-1235-2026 REASON: Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid...Read More
Company: Intuitive Surgical, Inc Date of Enforcement Report: 2/2/2026 Class: II PRODUCT: Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three...Read More
Company: Medtronic MiniMed, Inc Date of Enforcement Report: 2/2/2026 Class: II PRODUCT: MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more....Read More
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