Recall Z-2930-2026
Terumo Medical Corporation · initiated June 15, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
Reason for recall
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-2930-2026
- Initiated
- June 15, 2026
- Posted by FDA
- August 10, 2026
- Product code
- DYB – Introducer, Catheter
- Quantity
- 7,490 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recalling firm
- Terumo Medical Corporation, Elkton, MD