Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
FDA device recall Z-1004-2026 · posted 2025-12-30 · Open, Classified
Recall details
- Recalling firm
- Vortex Surgical Inc.
- Reason for recall
- Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
- Action taken
- Vortex Surgical Inc. issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/19/2025 via email. The notice explained the issue, risk to health, and requested the use of the product be discontinued. The firm requested the response to be emailed to: ARitts@VortexSurgical.com for replacement or refund. Customer Service will provide a return label for any unused products.
- Root cause
- Component design/selection
- Status
- Open, Classified
- Product code
- HQB
- Quantity affected
- 221 units
- Distribution
- US and Japan
- Date initiated
- 2025-11-19
- Date posted
- 2025-12-30
- Location
- Saint Charles, MO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers (K220263) | Vortex Surgical, Inc. | 2022-11-03 |