Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;

FDA Recall Z-1004-2026 · Posted 2025-12-30

Recalling FirmVortex Surgical Inc.
Recall StatusOpen, Classified
Product CodeHQB
Date Initiated2025-11-19
Product Quantity221 units

Reason for Recall

Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.

Firm Action

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: [email protected] for replacement or refund. Customer Service will provide a return label for any unused products.

Root Cause

Component design/selection

Distribution Pattern

US and Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K220263Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical ChandeliersVortex Surgical, Inc. · 2022-11-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑