Recall Z-1248-2026— Vortex Surgical Inc.
Class II · Ongoing
Class II FDA medical device recall by Vortex Surgical Inc., initiated 2025-12-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 25GA Subretinal Injection Cannula VS0220.25. 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
Product description
25GA Subretinal Injection Cannula VS0220.25
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.