Z-1004-2026Class II

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

Name: Z-1004-2026 Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25
Creator: Vortex Surgical Inc.
Published: 2025-11-19
License: https://open.fda.gov/license/

Vortex Surgical, Inc. / initiated 2025-11-19 / Open, Classified / root cause: design

FDA source

Vortex Surgical Inc. began a recall of Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25 on 2025-11-19. FDA classified it as Class II and gives the reason as "Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1004-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-19
Posted: 2025-12-30
Recalling firm: Vortex Surgical, Inc.
Product: Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Product code: HQB Photocoagulator And Accessories
Reason for recall: Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 221 units
Distribution: US and Japan
Product codes and lots: UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1004-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1004-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-07	2025-12-30

Product code HQB

K220263Class IIVortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical ChandeliersVortex Surgical, Inc. / cleared 2022-11-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)