Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Summary
The FDA issued a Class II for Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25; by Vortex Surgical Inc.. Reason: Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly..
Details
Source
Device Recall
External ID
Z-1004-2026
Action Date
2026-01-07
Status
Ongoing
Category
device
Product Description
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Lot/Code Info: UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040
Quantity Affected: 221 units
Reason for Recall
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Distribution
US and Japan
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-19
Company
Saint Charles, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 85 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Vortex Surgical Inc. has 16 FDA actions in our database, including 15 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Vortex Surgical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vortex Surgical Inc. have FDA actions?
Vortex Surgical Inc. has 16 FDA actions in our database, including 15 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1004-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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