FDA recall Z-1457-2025

MEDLINE INDUSTRIES, LP - Northfield · Class I · device

Product

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK

Reason for recall

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.

Distribution

US: CA, FL, MN, NY, OH, OR, PA, TX, WV

Key facts

Status: Ongoing
Initiation date: 2025-02-21
Report date: 2025-04-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1457-2025