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U.S. Department of Health and Human Services

Class 2 Device Recall GLIDESHEATH SLENDER

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 Class 2 Device Recall GLIDESHEATH SLENDERsee related information
Date Initiated by FirmJune 15, 2026
Date PostedAugust 10, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2930-2026
Recall Event ID 99285
510(K)NumberK173831 
Product Classification Introducer, catheter - Product Code DYB
ProductGLIDESHEATH 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 Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.
FEI Number 1118880
Recalling Firm/
Manufacturer		 Terumo Medical Corporation
950 Elkton Blvd
Elkton MD 21921-5322
For Additional Information ContactKimberly Feitl
`-800-2837866
Manufacturer Reason
for Recall		Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
FDA Determined
Cause 2		Under Investigation by firm
ActionTerumo 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 in Commerce7,490 units
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DYB
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