Recall Z-2930-2026— Terumo Medical Corporation

Name: FDA recall Z-2930-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-15

Class II · Ongoing

Class II FDA medical device recall by Terumo Medical Corporation, initiated 2026-06-15. It names one FDA 510(k) clearance: K173831. Product: GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.. Reason: Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire..

Recalling firm: Terumo Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-06-15
Firm location: Elkton, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K173831 — Glidesheath SlenderTerumo Medical Corporation·cleared 2018-05-08

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

GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.

Reason for recall

Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

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