FDA recall Z-1781-2026

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 for recall

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

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2026-03-05

Report date

2026-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1781-2026