CLASS II ONGOING Device recall · Reported 19 Aug 2026 · FDA Enforcement Report

Glidesheath Slender A-kit 6f .021gw recalled by Terumo Medical

Terumo Medical is recalling Glidesheath Slender A-kit 6f .021gw, distributed nationwide in the US. The recall was initiated on 15 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.

Quantity recalled7,490 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2930-2026
FDA event ID: 99285
Recalling firm: Terumo Medical, Elkton, MD
Classification: Class II
Status: Ongoing
Recall initiated: 15 Jun 2026
FDA classified: 10 Aug 2026
Reported: 19 Aug 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

15 Jun 2026	Recall initiated by company
10 Aug 2026	Classified by FDA	+56 days
19 Aug 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Terumo Medical

All 39

Reported	Class	Recall	Company	Reason	Where
31 Jul 2019Device	CLASS II	Terumo Sur-vet Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states
31 Jul 2019Device	CLASS II	Terumo Sur-vet Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states
31 Jul 2019Device	CLASS II	Terumo Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states
31 Jul 2019Device	CLASS II	Terumo Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states
31 Jul 2019Device	CLASS II	Terumo Sur-vet Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states

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