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Recall Observatory FDA recall evidence

Device product

Vortex Surgical TID Pharos Illuminated Depressor, VS0801B

Z-1254-2026

December 16, 2025

Class II

Product summary

Firm
Vortex Surgical Inc.
Event
Event 98255
Status
Ongoing
Classification
Class II
Quantity
14,789 (8651 US; 6138 OUS)
Official record key
device-enforcement:Z-1254-2026

Official wording

Reason: XXX

Code information: Pouch UDI 810123481309 Box UDI 810123481712 Lot 2403027R

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    XXX