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

Vortex Disposable Forceps and Cannula recalled by Vortex Surgical

Vortex Surgical is recalling Vortex Disposable Forceps and Cannula 1, 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. 23GA ACTU8 Forceps Adaptive Pouch UDI 810123481125 Box UDI 810123481538 Lot 2411009 2. 25GA ACTU8 Forceps Adaptive Pouch UDI 810123481132 Box UDI 810123481545 Lot 2410051 3. 25GA ACTU8 Forceps ILM Pouch UDI 810123481231 Box UDI 810123481644 Lot 2410021 2410053 2411006 4. 25GA ACTU8 Forceps ILM -Myopic Pouch UDI 810123481248 Box UDI 810123481651 Lot 2410059 5. 25GA ACTU8 Forceps Pro-Grip Pouch UDI 810123481101 Box UDI 810123481514 Lot 2410050 2411011 6. 25GA ACTU8 Talon Forceps ILM Pouch UDI 810123481835 Box UDI 810123481859 Lot 2411003 7. 25GA ACTU8 Talon Forceps Pro-Grip Pouch UDI 810123482375 Box UDI 810123482405 Lot 2410060 8. 27GA ACTU8 Forceps ILM Pouch UDI 810123481255 Box UDI 810123481668 Lot 2410054 9. 23GA Soft Tip Cannula UDI Pouch 810123480302 Box UDI 810123480562 Lot 2410037 10. 23GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480388 Box UDI 810123480661 Lot 2411032 11. 25GA Soft Tip Cannula UDI Pouch 810123480319 Box UDI 810123480586 Lot 2410039 12. 25GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480395 Box UDI 810123480678 Lot 2410041 13. 25GA Soft Tip Cannula - 0.5mm - Bulk UDI Pouch 810123480395 Box UDI 810123481927 Lot 2410042 2411018 14. 25GA Soft Tip Cannula-Bulk UDI Pouch 810123480319 Box UDI 810123480593 Lot 2410040 15. 27GA Soft Tip Cannula UDI Pouch 810123480326 Box UDI 810123480609 Lot 2412026

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-1247-2026
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: Sterility
Device type: Heart & Vascular 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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27

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

Why was it recalled?

Which lots are affected?

1. 23GA ACTU8 Forceps Adaptive Pouch UDI 810123481125 Box UDI 810123481538 Lot 2411009 2. 25GA ACTU8 Forceps Adaptive Pouch UDI 810123481132 Box UDI 810123481545 Lot 2410051 3. 25GA ACTU8 Forceps ILM Pouch UDI 810123481231 Box UDI 810123481644 Lot 2410021 2410053 2411006 4. 25GA ACTU8 Forceps ILM -Myopic Pouch UDI 810123481248 Box UDI 810123481651 Lot 2410059 5. 25GA ACTU8 Forceps Pro-Grip Pouch UDI 810123481101 Box UDI 810123481514 Lot 2410050 2411011 6. 25GA ACTU8 Talon Forceps ILM Pouch UDI 810123481835 Box UDI 810123481859 Lot 2411003 7. 25GA ACTU8 Talon Forceps Pro-Grip Pouch UDI 810123482375 Box UDI 810123482405 Lot 2410060 8. 27GA ACTU8 Forceps ILM Pouch UDI 810123481255 Box UDI 810123481668 Lot 2410054 9. 23GA Soft Tip Cannula UDI Pouch 810123480302 Box UDI 810123480562 Lot 2410037 10. 23GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480388 Box UDI 810123480661 Lot 2411032 11. 25GA Soft Tip Cannula UDI Pouch 810123480319 Box UDI 810123480586 Lot 2410039 12. 25GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480395 Box UDI 810123480678 Lot 2410041 13. 25GA Soft Tip Cannula - 0.5mm - Bulk UDI Pouch 810123480395 Box UDI 810123481927 Lot 2410042 2411018 14. 25GA Soft Tip Cannula-Bulk UDI Pouch 810123480319 Box UDI 810123480593 Lot 2410040 15. 27GA Soft Tip Cannula UDI Pouch 810123480326 Box UDI 810123480609 Lot 2412026

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

Other products in this recall event

12 other products · FDA event 98255

This product is part of a recall event; the main page for the event is Convenience Kits recalled by Vortex Surgical.

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026	CLASS II	Convenience Kits recalled by Vortex Surgical	Vortex Surgical	Sterility	Nationwide
11 Feb 2026	CLASS II	1. Laser Probe Curved recalled by Vortex Surgical	Vortex Surgical	Sterility	Nationwide
11 Feb 2026	CLASS II	TID Pharos Illuminated Depressor, VS0801B recalled by Vortex Surgical	Vortex Surgical	Other	Nationwide
11 Feb 2026	CLASS II	I2 Injection Kit, VS0500 recalled by Vortex Surgical	Vortex Surgical	Sterility	Nationwide
11 Feb 2026	CLASS II	Backflush, VS0270.25 recalled by Vortex Surgical	Vortex Surgical	Sterility	Nationwide
11 Feb 2026	CLASS II	Oertli 1. Laser Probe OS4 Flex-Tip VK401113 2. Laser Probe recalled	Vortex Surgical	Sterility	Nationwide
11 Feb 2026	CLASS II	I.D.D. Internal Delivery Device, VS0250.25 recalled by Vortex Surgical	Vortex Surgical	Sterility	Nationwide
11 Feb 2026	CLASS II	Tecfen Retractable Membrane Polisher, QTPR1267 recalled	Vortex Surgical	Sterility	Nationwide
11 Feb 2026	CLASS II	Subretinal Injection Cannula VS0220.25 recalled by Vortex Surgical	Vortex Surgical	Sterility	Nationwide
11 Feb 2026	CLASS II	Volk Single Use Vitrectomy Lenses Flat Vitrectomy Lens recalled	Vortex Surgical	Sterility	Nationwide
11 Feb 2026	CLASS II	Rumex Disposable Diamond Dusted ILM Elevator recalled by Vortex Surgical	Vortex Surgical	Sterility	Nationwide
11 Feb 2026	CLASS II	Lindsell Sutured IOL Marker, VS0390 - Scleral Marker recalled	Vortex Surgical	Sterility	Nationwide

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	Sterility	Nationwide
11 Feb 2026Device	CLASS II	Rumex Disposable Diamond Dusted ILM Elevator recalled by Vortex Surgical	Vortex Surgical	Sterility	Nationwide
11 Feb 2026Device	CLASS II	Volk Single Use Vitrectomy Lenses Flat Vitrectomy Lens recalled	Vortex Surgical	Sterility	Nationwide
11 Feb 2026Device	CLASS II	Subretinal Injection Cannula VS0220.25 recalled by Vortex Surgical	Vortex Surgical	Sterility	Nationwide
11 Feb 2026Device	CLASS II	Tecfen Retractable Membrane Polisher, QTPR1267 recalled	Vortex Surgical	Sterility	Nationwide

Other Heart & Vascular Devices recalls

All 6,220

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	TufTex¿ Over-the-Wire Embolectomy Catheter recalled	LeMaitre Vascular	Other	Nationwide
14 Oct 2026Device	CLASS II	Endovascular Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide