Vortex Surgical
15 federal recalls on file, showing the 14 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Vortex Surgical and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-02-11FDA-DeviceClass IIStop using Vortex Surgical scleral markers
Vortex Surgical has recalled certain lots of the Lindsell Sutured IOL Marker (a scleral marker used in eye surgery) because the sterile Tyvek pouches may have small voids or openings in their seals. A compromised seal can allow bacteria to enter the package, which could contaminate the sterile device and lead to infection if used in surgery.
- 2026-02-11FDA-DeviceClass IIStop using Vortex Surgical 25GA and 27GA Backflush needles
Vortex Surgical has recalled certain 25GA Backflush and 27GA Backflush Retractable surgical needles because their Tyvek sterile packaging pouches may have small voids in the seal. A damaged seal can allow bacteria to contaminate the needle, which could cause infection if used in surgery.
- 2026-02-11FDA-DeviceClass IIVortex Surgical TID Pharos Illuminated Depressor, VS0801B
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- 2026-02-11FDA-DeviceClass IIStop using Vortex Surgical Rumex ILM Elevator
Vortex Surgical Inc. is recalling certain lots of the Rumex Disposable Diamond Dusted ILM Elevator (catalog 12-7523) because the sterile packaging may have small voids in the seal. A compromised seal could allow bacteria or other contaminants to reach the surgical instrument, potentially leading to infection if used.
- 2026-02-11FDA-DeviceClass IIStop using Vortex Surgical I2 Injection Kit
Vortex Surgical I2 Injection Kits (model VS0500) in certain lots may have small voids or gaps in the seal of their sterile Tyvek pouches. This damage can allow bacteria to contaminate the sterile contents, potentially causing infection if the kit is used.
- 2026-02-11FDA-DeviceClass IIStop using Vortex Surgical Tecfen Polisher lot 2411013
Vortex Surgical Inc. is recalling Tecfen Retractable Membrane Polisher units (lot 2411013) because the Tyvek sterile pouches may have seal voids that compromise the sterile barrier. This could allow bacterial contamination and increase the risk of infection if the device is used.
- 2026-02-11FDA-DeviceClass IIStop using Vortex Surgical 25GA I.D.D. device
Vortex Surgical has recalled certain batches of its 25GA I.D.D. Internal Delivery Device (model VS0250.25) because the Tyvek sterile pouches may have small voids or gaps in their seals. A compromised seal can allow bacteria or other contamination to enter the package, potentially leading to infection if the device is used.
- 2026-02-11FDA-DeviceClass IIStop using Vortex Surgical 25GA Convenience Kits
Vortex Surgical Inc. is recalling three models of 25GA Convenience Kits because the Tyvek pouches may have voids or defects in their seals. A compromised seal can allow bacteria to contaminate the sterile contents, potentially leading to infection if the kits are used.
- 2026-02-11FDA-DeviceClass IIDo not use Vortex Surgical injection cannula
Vortex Surgical Inc. is recalling certain 25GA Subretinal Injection Cannula (model VS0220.25, Lot 2410043) because the sterile Tyvek pouches may have small voids or gaps in the seal. If a pouch is compromised, the cannula inside is no longer sterile and could become contaminated with bacteria, risking infection during eye surgery.
- 2026-02-11FDA-DeviceClass IIStop using recalled Vortex Surgical forceps and cannula
Vortex Surgical Inc. is recalling specific lots of disposable forceps and cannula instruments used in eye surgery because the Tyvek pouches protecting them may have seal voids. A compromised sterile barrier can allow bacterial contamination, potentially leading to infection during or after surgery.
- 2026-02-11FDA-DeviceClass IICheck Vortex Surgical laser probe packaging
Vortex Surgical has recalled certain Oertli laser probes used in eye surgery because the sterile packaging (Tyvek pouches) may have small voids or gaps in the seal. A compromised seal could allow bacteria to contaminate the sterile device, potentially leading to infection during surgery.
- 2026-02-11FDA-DeviceClass IIStop using Vortex Surgical laser probes
Vortex Surgical laser probes used in eye surgery may have small voids or gaps in their sterile packaging seals. If the seal is compromised, bacteria could contaminate the sterile device and cause infection during surgery. No injuries have been reported so far.
- 2026-02-11FDA-DeviceClass IIStop using affected Volk vitrectomy lenses
Volk Surgical's single-use vitrectomy lenses (Flat Vitrectomy Lens and Volk Magnifying Lens) in certain lots may have voids or breaks in their Tyvek sterile pouches. A compromised sterile barrier can allow bacterial contamination, which could lead to infection during eye surgery.
- 2026-01-07FDA-DeviceClass IIStop using Vortex Surgical laser probe (lot 2509040)
Some units of the Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe (catalog VS0135.25, lot 2509040) may not fit smoothly through a 25-gauge cannula as intended. This could affect proper use during medical procedures. The recall affects 221 units distributed in the US and Japan.
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