Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe recall (Vortex Surgical Inc.)
Medical deviceClass IIOngoing
Summary: Vortex Surgical Inc. is recalling Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;. Reason: Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
What is being recalled
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Why
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US and Japan
How to tell if yours is affected
UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1004-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | November 19, 2025 |
| Reported | January 7, 2026 |
| Company | Vortex Surgical Inc. |
| Company location | Saint Charles, MO, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 221 units |
More recalls from Vortex Surgical Inc. · all medical device recalls · recalls from November 2025