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Recall Observatory FDA recall evidence

Device 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

Z-1249-2026

December 16, 2025

Class II

Product summary

Firm
Vortex Surgical Inc.
Event
Event 98255
Status
Ongoing
Classification
Class II
Quantity
14,789 (8651 US; 6138 OUS)
Official record key
device-enforcement:Z-1249-2026

Official wording

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.

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    contamination which could lead
  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    bioburden contamination
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    compromised sterile barrier