Recall Z-1244-2026— Vortex Surgical Inc.

Name: FDA recall Z-1244-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-16

Class II · Ongoing

Class II FDA medical device recall by Vortex Surgical Inc., initiated 2025-12-16. It names one FDA 510(k) clearance: K050623. Product: Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD. Reason: 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..

Recalling firm: Vortex Surgical Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-12-16
Firm location: Saint Charles, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K050623 — VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV DVolk Optical, Inc.·cleared 2005-03-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.