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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
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.
Vortex Surgical recalled 14,789 disposable forceps and cannula on December 16, 2025, due to potential bioburden contamination. The recall affects various models distributed worldwide, including 8,651 in the U.S. and 6,138 internationally. Users should stop using these devices immediately to prevent infection risk.
Vortex Surgical recalled 14,789 units of its Lindsell Sutured IOL Marker on December 16, 2025. The recall stems from potential voids in the seal of Tyvek pouches, risking bioburden contamination. Healthcare providers and patients must stop using the device immediately.
Vortex Surgical recalled 14,789 laser probes on December 16, 2025, due to potential contamination risks. The recall affects devices distributed worldwide, including 8,651 units in the U.S. Consumers should stop using these devices immediately.
Vortex Surgical recalled 14,789 laser probes on December 16, 2025, due to potential bioburden contamination. The recall affects multiple catalog numbers distributed worldwide. Healthcare providers and patients must stop using these devices immediately.
Vortex Surgical recalled 14,789 Tecfen Retractable Membrane Polishers on December 16, 2025. The recall stems from potential voids in Tyvek pouches that may compromise sterility and lead to bioburden contamination. Healthcare providers and patients must stop using the products immediately.
Vortex Surgical recalled 14,789 units of its 25GA Subretinal Injection Cannula on December 16, 2025, due to a compromised sterile barrier. The recall affects devices distributed worldwide, including 8,651 units in the U.S. The issue may lead to bioburden contamination and potential infection.
Vortex Surgical recalled 14,789 Disposable Diamond Dusted ILM Elevators on December 16, 2025. The recall follows concerns about voids in the seal of Tyvek pouches, which could lead to bioburden contamination. Healthcare providers and patients should stop using the devices immediately.