Vortex Surgical recalled 14,789 surgical backflush pouches on December 16, 2025, due to compromised sterile barriers. The recall affects catalog numbers VS0270.25 and VS0275.27, with potential for bioburden contamination. Healthcare providers and patients should stop using these devices immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Vortex Surgical Inc. or your healthcare provider for instructions. Notification method: Letter
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The recall involves Vortex Surgical 25GA Backflush Pouches (Catalog Number VS0270.25) and 25GA Backflush Retractable Pouches (Catalog Number VS0275.27). These products were distributed worldwide, including all U.S. states and multiple foreign countries, and were sold in quantities of 14,789, with 8,651 in the U.S. and 6,138 internationally.
Voids in the seal of Tyvek pouches may compromise the sterile barrier of the surgical backflush pouches. This poses a high risk of bioburden contamination, which can lead to serious infections.
No specific incidents or injuries have been reported at this time. The high hazard level indicates a significant potential for infection risk.
Stop using the recalled surgical backflush pouches immediately. Follow the instructions provided by Vortex Surgical or your healthcare provider. For further information, contact Vortex Surgical Inc.
For more details, visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1255-2026. Patients should reach out to their healthcare providers for further guidance.
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