Recall Z-1249-2026— 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: Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES. 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
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
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.