# FDA 483 - Vortex Surgical Inc. - January 08, 2026

Source: https://www.globalkeysolutions.net/records/483/vortex-surgical-inc/a9376118-52e1-40ff-b42c-af81dcece7cb

> FDA 483 for Vortex Surgical Inc. on January 08, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vortex Surgical Inc.
- Inspection Date: 2026-01-08
- Product Type: device
- Office Name: Kansas City District Office
- Summary: Vortex Surgical Inc. in Saint Charles, MO, was inspected from January 6-8, 2026, and received one observation. The firm failed to adequately control nonconforming products, specifically Class II laser probes that were part of a recall, by improperly storing them without proper identification or adherence to company procedures and FDA commitments. This indicates a significant lapse in quality control for medical devices.

## Related Documents

- [483 - 2023-02-09](https://www.globalkeysolutions.net/records/483/vortex-surgical-inc/6a2eb734-29f7-4b6f-9fbb-615065db644c)

## Related Officers

- [Edward E. Lockwood](https://www.globalkeysolutions.net/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.globalkeysolutions.net/companies/vortex-surgical-inc/a846fc3d-c055-4bfe-9dc6-17229b6b775a

Office: https://www.globalkeysolutions.net/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79