FDA Enforcement
Class II
Ongoing
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
Recall: Z-1254-2026
·
Reported February 11, 2026
Enforcement
- Recall Number
- Z-1254-2026
- Event ID
- 98255
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Vortex Surgical Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 11, 2026
- Initiation Date
- December 16, 2025
- Classification Date
- February 4, 2026
- Address
- 4 Research Park Dr Ste 124, N/A, Saint Charles, MO, 63304-5639, United States
Description
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
Reason
XXX
Code Info
Pouch UDI 810123481309 Box UDI 810123481712 Lot 2403027R
Distribution
Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.
Quantity
14,789 (8651 US; 6138 OUS)