Vortex Surgical Inc.: Medical Device Recall in 2026 - (Recall #: Z-1252-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Vortex Surgical I2 Injection Kit, VS0500

Product Classification:

Class II

Date Initiated: December 16, 2025

Date Posted: February 11, 2026

Recall Number: Z-1252-2026

Event ID: 98255

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 14,789 (8651 US; 6138 OUS)

Code Information:

Pouch UDI 810123480920 Box UDI 810123481330 Lot 2411012

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.

Voluntary or Mandated:

Voluntary: Firm initiated