FDA Medical devices recall ·
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe recall
- Recall number
- Z-1004-2026
- Date
- (initiated November 19, 2025)
- Company / brand
- Vortex Surgical Inc.
4 Research Park Dr Ste 124, Saint Charles, MO, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 221 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Why was it recalled?
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040
Distribution
US and Japan
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1004-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.