Vortex Surgical Inc.: Device Recall

Recall Details

Recall Number

Z-1254-2026

Classification

Class II

Product Type

Device

Recalling Firm

Vortex Surgical Inc.

Status

Ongoing

Date Initiated

12/16/2025

Location

Saint Charles, MO, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

14,789 (8651 US; 6138 OUS)

Reason for Recall

XXX

Product Description

Vortex Surgical TID Pharos Illuminated Depressor, VS0801B

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.

Other Recalls by Vortex Surgical Inc.

• Class II: Risk 12/16/2025
  There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
• Class II: Risk 12/16/2025
  There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
• Class II: Risk 12/16/2025
  There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
• Class II: Risk 12/16/2025
  There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
• Class II: Risk 12/16/2025
  There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

View all recalls by Vortex Surgical Inc. →