Vortex Surgical recalled 14,789 units of its 25GA I.D.D. Internal Delivery Device on December 16, 2025. The recall stems from potential voids in the seal of Tyvek pouches that may compromise sterility, leading to infection risks. Healthcare providers and patients are urged to stop using the device immediately and follow recall instructions.
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 Vortex Surgical 25GA I.D.D. Internal Delivery Device is used in medical procedures to assist with internal delivery applications. Healthcare providers rely on its sterility for safe patient outcomes.
Voids in the seal of Tyvek pouches can compromise the device's sterile barrier, potentially allowing harmful microorganisms to contaminate the device and lead to infection.
This recall is not part of a broader industry pattern.
Consumers and healthcare providers must act swiftly to prevent potential infections. The recall poses significant safety concerns, necessitating immediate cessation of use and return of the device.
Product identification information, including catalog numbers and lots, can typically be found on the packaging or accompanying documentation.
Expect a timeline of 4-6 weeks for processing refunds or replacements.
Keep records of your purchase, any communications regarding the recall, and photos of the device as evidence.
The recalled product is the Vortex Surgical 25GA I.D.D. Internal Delivery Device, model VS0250.25. It was sold worldwide, including in the US and various foreign countries, with a total of 14,789 units recalled. The affected catalog number includes Pouch UDI 810123480456 and Box UDI 810123480739, Lot 2410044.
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