Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe… recallZ-1004-2026 · Vortex Surgical Inc. · initiated Nov 19, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Vortex Surgical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
FDA root cause category: Component design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-1004-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 19, 2025
- Posted by the FDA
- Dec 30, 2025
- Recalling firm
- Vortex Surgical Inc.
- Quantity
- 221 units
- Product code
- HQB
- FDA submissions
- K220263
- Distribution
- US and Japan
Product description
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Code information (models, lots, serial numbers)
UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vortex Surgical Inc. VS0135.25Vortex Surgical, Inc. · Photocoagulator And Accessories1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page