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Open, Classified

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.

FDA Recall Z-2930-2026 · Posted 2026-08-10

Recall StatusOpen, Classified
Product CodeDYB
Date Initiated2026-06-15
Product Quantity7,490 units

Reason for Recall

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

Firm Action

Terumo Medical Corporation notified consignees on about 06/15/2026. Consignee were instructed to immediately isolate the affected lot number, 0001441871, arrange for the return of those affected units, notify any facilities or customers to which affected units have been further transferred or distributed, and complete and return the provided response form.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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