- Recalling firm
- Terumo Medical Corporation
- Reason for recall
- Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
- Affected products (lot / model / serial)
- Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
- Units affected
- 7,490 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the country of Canada.
- Firm location
- Elkton, MD, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2930-2026
- Recall initiated
- June 15, 2026
- FDA classification date
- August 10, 2026
- FDA report date
- August 19, 2026
- FDA event ID
- 99285
- Last updated on HTM Vibe
- August 26, 2026