FDA recall Z-1776-2026

Product

COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791

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-1776-2026