Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 61–66 of 66 recalls
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…
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.