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Z-2930-2026Class II

Terumo Medical Corporation

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Terumo Medical Corporation
Product type
Device
Status
Ongoing
Report date
2026-08-19
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Firm state
MD
Product quantity
7,490 units
Initiated by
Voluntary: Firm initiated
Reason for recall

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

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.

Code / lot info

Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →