Vortex Surgical Inc.: Device Recall

Recall #Z-1004-2026 · 11/19/2025

Class II: Risk

Recall Details

Recall Number: Z-1004-2026
Classification: Class II
Product Type: Device
Recalling Firm: Vortex Surgical Inc.
Status: Ongoing
Date Initiated: 11/19/2025
Location: Saint Charles, MO, United States
Voluntary/Mandated: Voluntary: Firm initiated
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.

Product Description

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

Distribution Pattern

US and Japan

Other Recalls by Vortex Surgical Inc.

Class II: Risk 12/16/2025

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Class II: Risk 12/16/2025

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Class II: Risk 12/16/2025

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Class II: Risk 12/16/2025

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Class II: Risk 12/16/2025

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

View all recalls by Vortex Surgical Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.