Official recall notice

FDA DeviceClass IINotable

Glidesheath Slender A-KIT 6F 10CM .021GW Recall (Aug 2026)

Product: 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.

Recall date
2026-08-19
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

Affected products

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

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