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 I recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 493–504 of 595 recalls
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 IOngoingZ-1512-2025
Qapel Medical Inc. recalls Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing
Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.
Qapel Medical Inc.CAApr 16, 2025
Class IOngoingZ-1505-2025
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY
Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
MEDLINE INDUSTRIES, LP…ILApr 16, 2025
Class IOngoingZ-1459-2025
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits
Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
MEDLINE INDUSTRIES, LP…ILApr 16, 2025
Class IOngoingZ-1458-2025
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits
Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
MEDLINE INDUSTRIES, LP…ILApr 16, 2025
Class IOngoingZ-1457-2025
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits
Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
MEDLINE INDUSTRIES, LP…ILApr 16, 2025
Class IOngoingZ-1456-2025
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical procedure kits
Medline medical procedure kits, containing Medtronic Aortic Root Cannula
MEDLINE INDUSTRIES, LP…ILApr 16, 2025