FDAFDA recall Z-2930-2026 · Aug 19, 2026
Terumo Medical Corporation: GLIDESHEATH SLENDER A-KIT 6F 10CM recall
Recall found
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 for recall
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
- Quantity
- 7,490 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recalling firm
- Terumo Medical Corporation, Elkton, MD
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-15
Source: openFDA enforcement record Z-2930-2026 · search recall number Z-2930-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.