FDA-Device2026-02-11Class IIPACKAGING DEFECT

Vortex Surgical 25GA I.D.D. Internal Delivery Device recalled for compromised sterile packaging

Nationwide distributionMedical devices

What this means

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.

The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

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-1250-2026

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