Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 16, 2025 |
| Reported | February 11, 2026 |
| Recalling firm | Vortex Surgical Inc. |
| Country / region | United States MO |
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.
Affected products
- Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
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