Z-2930-2026Class II

GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box

Name: Z-2930-2026 GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box
Creator: Terumo Medical Corporation
Published: 2026-06-15
License: https://open.fda.gov/license/

Terumo Medical Corp. / initiated 2026-06-15 / Open, Classified / root cause: packaging

FDA source

Terumo Medical Corporation began a recall of 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... on 2026-06-15. FDA classified it as Class II and gives the reason as "Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2930-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-15
Posted: 2026-08-10
Recalling firm: Terumo Medical Corp.
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.
Product code: DYB Introducer, Catheter
Reason for recall: Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Terumo 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 commerce: 7,490 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2930-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2930-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-10

Product code DYB

K173831Class IIGlidesheath SlenderTerumo Medical Corporation / cleared 2018-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)