FDA Medical Device Recalls (openFDA)
Vortex Surgical Inc.: Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
- Recall number
- Z-1004-2026
- Recalling firm
- Vortex Surgical Inc.
- Product
- Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
- Status
- Open, Classified
- Initiated
- 2025-11-19
- Posted
- 2025-12-30
- Terminated
- not on file
- Reason
- Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
- 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: ARitts@VortexSurgical.com for replacement or refund. Customer Service will provide a return label for any unused products.
- Quantity
- 221 units
- Distribution
- US and Japan
- Lot, serial or model codes
- UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040
- 510(k) numbers
- K220263
- PMA numbers
- not on file
- Product code
- HQB
- Firm FEI
- 3013002167
- Firm city
- Saint Charles
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28