FDA-Device2026-02-11Class IIPACKAGING DEFECT
Vortex Surgical 25GA I.D.D. Internal Delivery Device recalled for compromised sterile packaging
Nationwide distribution
Stop using Vortex Surgical 25GA I.D.D. device
Vortex Surgical has recalled certain batches of its 25GA I.D.D. Internal Delivery Device (model VS0250.25) because the Tyvek sterile pouches may have small voids or gaps in their seals. A compromised seal can allow bacteria or other contamination to enter the package, potentially leading to infection if the device is used.
- Stop using the device immediately if you have lot 2410044 or the affected catalog numbers.
- Contact your healthcare facility or Vortex Surgical to verify whether your device is affected.
- Do not use any affected device for surgery or medical procedures.
- Return the device to Vortex Surgical or your supplier for a replacement or refund.
Hazard
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.
Sold states
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.
Affected count
14,789 (8651 US; 6138 OUS)
Manufactured in
4 Research Park Dr Ste 124, N/A, Saint Charles, MO, United States
Products
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1250-2026Don't want to check this manually?
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