FDAFDA · Food and drugs·Recall number Z-2930-2026
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.
Published August 19, 2026 · Recall initiated: June 15, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Terumo Medical Corporation
- Distributor
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot
- Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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