Recall Z-1781-2026— Cook Incorporated

Name: FDA recall Z-1781-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-05

Class II · Ongoing

Class II FDA medical device recall by Cook Incorporated, initiated 2026-03-05. It names one FDA 510(k) clearance: K133597. 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.. Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life..

Recalling firm: Cook Incorporated
Classification: Class II
Status: Ongoing
Initiated: 2026-03-05
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K133597 — CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAYCook, Inc.·cleared 2014-04-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Data sourced from openFDA. This site is unofficial and independent of the FDA.