Data Foundry

Medical device recalls 2026

Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe — Class II medical device recall Z-1004-2026

Ongoing recall by Vortex Surgical Inc., reported 2026-01-07. Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.

Recall numberZ-1004-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmVortex Surgical Inc., Saint Charles, MO, United States
Recall initiated2025-11-19
Classified2025-12-30
Reported by FDA2026-01-07
Countries outside the USJP
Quantity221 units
UPC / GTIN / UDI-DI00810123483549, 00810123483617
Lot numbers2509040
Model numbersVS0135.25

Product

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

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1004-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.