Recall Ledger

GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. ... recall (Terumo Medical Corporation)

Medical deviceClass IIOngoing

Summary: Terumo Medical Corporation is recalling 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: Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

What is being recalled

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.

Why

Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide distribution - US Nationwide and the country of Canada.

How to tell if yours is affected

Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2930-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJune 15, 2026
ReportedAugust 19, 2026
CompanyTerumo Medical Corporation
Company locationElkton, MD, United States
Initiated byVoluntary: Firm initiated
Quantity7,490 units

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