DeviceSignal · Recall classified
Terumo Medical Corporation
FDA classified a device recall on 2026-08-10 · Class II · Z-2930-2026
EventRecall classified
Effective2026-08-10
ClassificationClass II
On 2026-08-10 the FDA classified a device recall from Terumo Medical Corporation as Class II. Product: GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The…. Recall Z-2930-2026. The firm initiated it on 2026-06-15. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2930-2026
- Classification
- Class II
- Classified on
- 2026-08-10
- Initiated on
- 2026-06-15
- Firm
- Terumo Medical Corporation
- Reason
- Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
- 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.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2930-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
28020fe5af6b6b357c0003b5b813ab9995082868452b887550c20d38cedcf2d4- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)