Vortex Surgical Inc. 2026-02-11 Health serious FDA
Health · FDA · Recall #FDA-Z-1249-2026
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience… Recall
Issued February 11, 2026 · Vortex Surgical Inc.
In February 2026, Vortex Surgical Inc. recalled the Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Vortex Surgical Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Vortex Surgical Inc.
- Category
- Health
- Recall date
- February 11, 2026
- Units affected
- Not reported
- Sold at
- 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
- Recall number
- FDA-Z-1249-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Vortex Surgical Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.