FDAHealthDecember 16, 2025
Vortex Surgical Inc. — Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
⚠️ XXX
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 16, 2025
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.
What's affected?
- Product
- Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
- Brand
- Vortex Surgical Inc.
- Lot code
- 2403027R
Additional details
Pouch UDI 810123481309 Box UDI 810123481712 Lot 2403027R
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 14,789 (8651 US; 6138 OUS).
Get Health recall alerts
Delivered to your inbox. Free. No account required.