Terumo Medical Corporation recalls GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. Th…
Reason for recall
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- UDI
- 30389701011975; Pouch
- UDI
- 00389701011974; UDI-PI: (17)280501(10)0001441871
- Lot #
- 0001441871
What the firm is doing
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.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the country of Canada.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2930-2026
- FDA 510(k) clearance · K173831The device's official FDA premarket clearance record
- FDA device classification · DYBOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1340The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Terumo Medical CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Medline Industries, LP recalls Medline Convenience Kits: 1) ANTERIOR SPINE PACK
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neu…
- Orthopedic Tray
- Nonconforming Material/Component
Medline Industries, LP recalls Medline Convenience Kits: 1) MAJOR NEURO VCH
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neu…
- Neurological Tray
- Nonconforming Material/Component
Medline Industries, LP recalls Medline Convenience Kits: 1) MFC CRANIOTOMY PACK
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neu…
- General Surgery Tray
- Nonconforming Material/Component
