FDA Device recall Z-2930-2026
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box
- FDA Device
- Class II
- ongoing
- Published 2026-08-19
On 2026-08-19 the FDA classified a Class II recall of GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box by Terumo Medical, citing product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2930-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-15 |
| Published | 2026-08-19 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Terumo Medical |
| Distribution | US |
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.
Reason
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Identifiers
| code_info | Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2930-2026%22
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