Vortex Surgical Inc. recalls Vortex Surgical TID Pharos Illuminated Depressor
Reason for recall
XXX
Affected product
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Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Vortex Surgical TID Pharos Illuminated DepressorVS0801BUDI 810123481309Affected lot2403027R
What the firm is doing
On December 16, 2025, the firm began notifying customers via "URGENT: MEDICAL DEVICE RECALL" letters. Customers were instructed to discontinue use of affected product and to return product for Vortex Surgical to evaluate the seals; use UPS account 23623Y to ship unused products to Vortex Surgical Inc for replacement or refund at: Attn: Andrew Ritts Recall Tyvek Seal, Vortex Surgical Inc., 4 Research Park Dr., Suite 124, St. Charles, MO 63304; complete and return the Acknowledgement and Receipt Form via mail or email to: ARitts@VortexSurgical.com. Actions have been implemented to improve training of individuals associated with sealing and inspecting seals to prevent reoccurrence. The sealer associated with the issue is being updated to include a guard to prevent reoccurrence. If you have any questions, contact the Director of Regulatory Affairs at 635-778-4350 or email to: ARitts@VortexSurgical.com from 8am to 5pm.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1254-2026
- FDA device classification · HJMOfficial FDA classification for this device type
- CFR regulation · 21 CFR 886.1945The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Vortex Surgical Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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