Recall Z-1775-2026— Cook Incorporated

Name: FDA recall Z-1775-2026
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: K171897. Product: COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786. 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

K171897 — Approach CTO Microwire GuideCook Incorporated·cleared 2017-08-21

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 Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786

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.