Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2930-2026·Announced 2026-08-19

Terumo Glidesheath Slender A-Kit Recalled for Incorrect Guidewire Packaging

Terumo Medical Corporation is recalling 7,490 units of Glidesheath Slender A-Kits because they were packaged with a 0.025 guidewire instead of the specified 0.021 guidewire.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The hazard involves a packaging error with the wrong guidewire size, which is a significant quality issue but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I).

Plain-English summary

Terumo Medical Corporation is voluntarily recalling 7,490 units of the Glidesheath Slender A-Kit, Product Code 60-1060. The device is used to facilitate placing a catheter through the skin into the radial artery. The recall was initiated because the product was packaged with a 0.025 guidewire instead of the correct 0.021 guidewire.

The affected units were distributed worldwide, including across the United States and Canada. The specific lot number for the recalled product is 0001441871. The shelfbox UDI-DI is 30389701011975 and the pouch UDI-DI is 00389701011974.

Healthcare providers and facilities should check their inventory for this specific product code and lot number. If the product is found, it should be removed from use and returned to the manufacturer or their authorized representative according to standard recall procedures.

The recalled product

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.
Manufacturer: Terumo Medical Corporation
Category: Medical Device — Catheter Accessories
Hazard: mis-labeling
packaging-error
Affected units: 7,490

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

Same manufacturer · Terumo Medical Corporation

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Same hazard · mis labeling