Class IOngoingZ-1527-2025
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-…
Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.GAApr 23, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 2,065–2,076 of 2,908 recalls
Class IOngoingZ-1526-2025
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271…
Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.GAApr 23, 2025
Class IOngoingZ-1525-2025
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210…
Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.GAApr 23, 2025
Class IOngoingZ-1524-2025
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2201…
Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.GAApr 23, 2025
Class IOngoingZ-1523-2025
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2008…
Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.GAApr 23, 2025
Class IOngoingZ-1522-2025
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210…
Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.GAApr 23, 2025
Class IOngoingZ-1521-2025
Avanos Medical, Inc. recalls Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198…
Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.GAApr 23, 2025
Class IOngoingZ-1520-2025
Tandem Diabetes Care, Inc. recalls Tandem Mobi Insulin Pump with Interoperable Technology
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Gl…
Tandem Diabetes Care,…CAApr 23, 2025
Class IOngoingZ-1519-2025
Tandem Diabetes Care, Inc. recalls t:slim X2 Insulin Pump with Interoperable Technology
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Gl…
Tandem Diabetes Care,…CAApr 23, 2025
Class IOngoingZ-1507-2025
Bard Access Systems, Inc. recalls BD 4 Fr Single-Lumen PowerPICC Catheters
Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to i…
Bard Access Systems, I…UTApr 23, 2025
Class IIOngoingZ-1551-2025
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C Reactive Protein (RCRP)
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
Siemens Healthcare Dia…NYApr 16, 2025
Class IIOngoingZ-1550-2025
CareFusion 303, Inc. recalls BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK…
Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order.…
CareFusion 303, Inc.CAApr 16, 2025