Z-2930-2026 Class II Ongoing
FDA device recall Z-2930-2026 was initiated by Terumo Medical Corporation on June 15, 2026 and is designated Class II. Reason for recall: Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. The recall status is ongoing. Affected quantity: 7,490 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2026
- Initiation Date
- June 15, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,490 units
Product Description
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.