medical Class II Updated 2026-02-11

Vortex Surgical Inc. recalls Vortex Surgical I2 Injection Kit, VS0500

Recalled Product

Vortex Surgical I2 Injection Kit, VS0500


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Pouch UDI 810123480920 Box UDI 810123481330 Lot 2411012
View official government recall

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