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

TID Pharos Illuminated Depressor, VS0801B recalled by Vortex Surgical

Vortex Surgical is recalling Vortex Surgical TID Pharos Illuminated Depressor, VS0801B, 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 810123481309 Box UDI 810123481712 Lot 2403027R

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-1254-2026
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: Other Reasons
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

XXX

Product as listed by the FDA

Vortex Surgical TID Pharos Illuminated Depressor, VS0801B

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 TID Pharos Illuminated Depressor, VS0801B recalled?

Yes. Vortex Surgical recalled TID Pharos Illuminated Depressor, VS0801B on 16 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1254-2026.

Why was it recalled?

XXX

Which lots are affected?

Pouch UDI 810123481309 Box UDI 810123481712 Lot 2403027R

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

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11 Feb 2026Device	CLASS II	Lindsell Sutured IOL Marker, VS0390 - Scleral Marker recalled	Vortex Surgical	Lead & Heavy Metals	Nationwide
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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

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