CLASS II ONGOING Device recall · Reported 11 Feb 2026 · FDA Enforcement Report

Oertli Laser Probe OS4 Flex-Tip VK401113 Laser Probe OS4 recalled

Vortex Surgical is recalling Oertli Laser Probe OS4 Flex-Tip VK401113 Laser Probe OS4 Illuminated Flex-Tip VK401213, distributed nationwide in the US. The recall was initiated on 16 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. 23G Laser Probe OS4 Flex-Tip Pouch UDI 810123483716 Box UDI 810123483792 Lot 2410031 2. 23G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483730 Box UDI 810123483815 Lot 2410034 3. 23G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483761 Box UDI 810123483846 Lot 2410033 4. 25G Laser Probe OS4 Flex-Tip Pouch UDI 810123483723 Box UDI 810123483808 Lot 2410032 2410058 2411022; 5. 25G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483747 Box UDI 810123483822 Lot 2410035 6. 25G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483778 Box UDI 810123483853 Lot 2412025 7. 27G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483785 Box UDI 810123483860 Lot 2411021

Quantity recalled14,789 (8651 US; 6138 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1246-2026
FDA event ID: 98255
Recalling firm: Vortex Surgical, Saint Charles, MO
Classification: Class II
Status: Ongoing
Recall initiated: 16 Dec 2025
FDA classified: 4 Feb 2026
Reported: 11 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

16 Dec 2025	Recall initiated by company
4 Feb 2026	Classified by FDA	+50 days
11 Feb 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327

Where it was distributed

Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.

Nationwide Alabama Arkansas Arizona California Connecticut Florida Hawaii Iowa Illinois Indiana Kentucky Massachusetts Michigan Minnesota Mississippi North Carolina Nebraska New Jersey New Mexico New York

Questions about this recall

Is Oertli Laser Probe OS4 Flex-Tip VK401113 Laser Probe OS4 Illuminated Flex-Tip VK401213 recalled?

Yes. Vortex Surgical recalled Oertli Laser Probe OS4 Flex-Tip VK401113 Laser Probe OS4 Illuminated Flex-Tip VK401213 on 16 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1246-2026.

Why was it recalled?

Which lots are affected?

1. 23G Laser Probe OS4 Flex-Tip Pouch UDI 810123483716 Box UDI 810123483792 Lot 2410031 2. 23G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483730 Box UDI 810123483815 Lot 2410034 3. 23G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483761 Box UDI 810123483846 Lot 2410033 4. 25G Laser Probe OS4 Flex-Tip Pouch UDI 810123483723 Box UDI 810123483808 Lot 2410032 2410058 2411022; 5. 25G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483747 Box UDI 810123483822 Lot 2410035 6. 25G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483778 Box UDI 810123483853 Lot 2412025 7. 27G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483785 Box UDI 810123483860 Lot 2411021

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Vortex Surgical

All 15

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026Device	CLASS II	Lindsell Sutured IOL Marker, VS0390 - Scleral Marker recalled	Vortex Surgical	Lead & Heavy Metals	Nationwide
11 Feb 2026Device	CLASS II	Rumex Disposable Diamond Dusted ILM Elevator recalled by Vortex Surgical	Vortex Surgical	Lead & Heavy Metals	Nationwide
11 Feb 2026Device	CLASS II	Volk Single Use Vitrectomy Lenses Flat Vitrectomy Lens recalled	Vortex Surgical	Lead & Heavy Metals	Nationwide
11 Feb 2026Device	CLASS II	Vortex Disposable Forceps and Cannula ACTU8 Forceps recalled	Vortex Surgical	Lead & Heavy Metals	Nationwide
11 Feb 2026Device	CLASS II	Subretinal Injection Cannula VS0220.25 recalled by Vortex Surgical	Vortex Surgical	Lead & Heavy Metals	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide