Reported Feb 11, 2026 · Ongoing
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA…
Vortex Surgical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vortex Surgical Inc. · 4 Research Park Dr Ste 124 · Saint Charles, MO · 63304-5639
Is this the product you have?
- 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
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 81012348291781012348292425GA Convenience Kit - FNX Pouch UDI 810123482917 Box UDI 810123482924 Lot 2410055 2 81012348242981012348244325GA Convenience Kit - FXX Pouch UDI 810123482429 Box UDI 810123482443 Lot 2411028 3 81012348241281012348243625GA Convenience Kit - XES Pouch UDI 810123482412 Box UDI 810123482436 Lot 2410057 - Amount recalled
- 14,789 (8651 US; 6138 OUS)
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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