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

I2 Injection Kit, VS0500 recalled by Vortex Surgical

Vortex Surgical is recalling I2 Injection Kit, VS0500, 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 codesPouch UDI 810123480920 Box UDI 810123481330 Lot 2411012

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-1252-2026
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: Surgical Instruments

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 Surgical I2 Injection Kit, VS0500

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?

Pouch UDI 810123480920 Box UDI 810123481330 Lot 2411012

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	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	Vortex Disposable Forceps and Cannula 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	Vortex Disposable Forceps and Cannula recalled by Vortex Surgical	Vortex Surgical	Sterility	Nationwide
11 Feb 2026Device	CLASS II	Subretinal Injection Cannula VS0220.25 recalled by Vortex Surgical	Vortex Surgical	Sterility	Nationwide

Other Surgical Instruments recalls

All 3,891

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Adaptable Beach Chair Beach Chair surgical patient positioner recalled	Quantum OPS	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	Laparoscopic Prostatectomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Halyard Laparoscopy Comprehensive Pack II recalled	GRI Medical & Electronic Technology	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide