FDA Medical devices recall ·
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box recall
- Recall number
- Z-2930-2026
- Date
- (initiated June 15, 2026)
- Company / brand
- Terumo Medical Corporation
950 Elkton Blvd, Elkton, MD, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7,490 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2930-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.