GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to fac
FDA device recall Z-2930-2026 · posted 2026-08-10 · Open, Classified
Recall details
- Recalling firm
- Terumo Medical Corporation
- Reason for recall
- Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- DYB
- Quantity affected
- 7,490 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Date initiated
- 2026-06-15
- Date posted
- 2026-08-10
- Location
- Elkton, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Glidesheath Slender (K173831) | Terumo Medical Corporation | 2018-05-08 |