Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 49–58 of 58 recalls
Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising;…
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label.
The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that…
Sterility assurance with procedure trays
Sterility assurance with procedure trays
Sterility assurance with procedure trays
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events.…