GLIDESHEATH SLENDER recallZ-2930-2026 · Terumo Medical Corporation · initiated Jun 15, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Terumo Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2930-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 15, 2026
- Posted by the FDA
- Aug 10, 2026
- Recalling firm
- Terumo Medical Corporation
- Quantity
- 7,490 units
- Product code
- DYB
- FDA submissions
- K173831
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
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.
Code information (models, lots, serial numbers)
Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- GLIDESHEATH SLENDER 60-1060Terumo Medical Corporation · INTRODUCER, CATHETER1 recall107 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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