Cook Incorporated recalls Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 S…

Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

On April 2, 2026, the firm began notifying affected consignees via letters titled "URGENT: MEDICAL DEVICE RECALL." Customers were instructed to quarantine affected products in inventory and to immediately cease further distribution and use of the affected products. They should return the affected products to Cook Medical with a copy of the completed Acknowledgement and Receipt form to receive a product credit.

• FDA enforcement recordOfficial FDA database entry for Z-1935-2026
• FDA 510(k) clearance · K162448The device's official FDA premarket clearance record
• FDA device classification · DQOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Cook IncorporatedSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.