FDA DevicesClass II
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Published: January 7, 2026Recall ID: Z-1004-2026Category: devicesCountry: US
Reason for Recall / Hazard
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Product Description & Identification
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Additional Source Details
| Field | Value |
|---|---|
| City | Saint Charles |
| State | MO |
| Event id | 98032 |
| Address 1 | 4 Research Park Dr Ste 124 |
| Address 2 | N/A |
| Code info | UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040 |
| Postal code | 63304-5639 |
| Report date | 20260107 |
| Product type | Devices |
| Product quantity | 221 units |
| Reason for recall | Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251119 |
| Initial firm notification | |
| Center classification date | 20251230 |
Overview
- Recalling FirmVortex Surgical Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS and Japan