Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
Reported: February 11, 2026 Initiated: December 16, 2025 #Z-1250-2026
Product Description
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
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.
Details
- Recalling Firm
- Vortex Surgical Inc.
- Units Affected
- 14,789 (8651 US; 6138 OUS)
- 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.
- Location
- Saint Charles, MO
Frequently Asked Questions
What product was recalled? ▼
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25. Recalled by Vortex Surgical Inc.. Units affected: 14,789 (8651 US; 6138 OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2026. Severity: Moderate. Recall number: Z-1250-2026.
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