Recall Z-2930-2026 ยท DYB Introducer, Catheter
Terumo Medical Corporation
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.
| Date | Aug 10, 2026 (initiated Jun 15, 2026) |
| Status | Open, Classified |
| Reason | Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 7,490 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173831 | Glidesheath Slender Terumo Medical Corporation, May 8, 2018 |