The FDA has posted 9 enforcement recalls of non-implanted triple lumen hemodialysis catheter devices since 2025, including 1 Class I (most serious) recall. Most recent report: Jul 8, 2026.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if ster…
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
A potential issue with the seal integrity of header bag packaging.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Catheter, Hemodialysis, Triple Lumen, Non-Implanted”). Informational only — verify against the FDA before acting.