Device recall

Z-1781-2026: COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set…

FDA device recall · Class II · Cook Incorporated

Key facts

Recall number (Z-number) Z-1781-2026
Recall event 98495
Product COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
Product code JOH
Recalling firm Cook Incorporated
Recall class Class II
Status Open, Classified
510(k) numbers K133597
FEI number 1820334

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)