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Recall Category: Medical Device Recalls
Recalling Firm: Vortex Surgical Inc.
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 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.
Classification: Class II
Status: Ongoing
Report Date: 02/11/2026
Recall Initiation Date: 12/16/2025
Distribution: 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, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.
Code Info: 1. 25GA Convenience Kit – FNX Pouch UDI 810123482917 Box UDI 810123482924 Lot 2410055 2. 25GA Convenience Kit – FXX Pouch UDI 810123482429 Box UDI 810123482443 Lot 2411028 3. 25GA Convenience Kit – XES Pouch UDI 810123482412 Box UDI 810123482436 Lot 2410057
Product Quantity: 14,789 (8651 US; 6138 OUS)
Recall Type: Voluntary: Firm initiated
Initial Firm Notification: Letter
Firm Location: Saint Charles, MO, United States
Recall Number: Z-1249-2026
Event ID: 98255