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RecallWatchMedical Device Safety
Class IIOngoingZ-1247-2026

Vortex Surgical Inc. recalls Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2…

Vortex Surgical Inc.Saint Charles, MO, United StatesReported Feb 11, 2026 · 5 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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 CannulaVS0200.27
    UDI 810123481125
    71 affected lots
    241100925GAACTU8810123481132810123481545241005125GAACTU8
    +63 more81012348123181012348164424100212410053241100625GAACTU8810123481248810123481651241005925GAACTU88101234811018101234815142410050241101125GAACTU8810123481835810123481859241100325GAACTU8810123482375810123482405241006027GAACTU8810123481255810123481668241005423GA810123480302810123480562241003723GA0.5mm810123480388810123480661241103225GA810123480319810123480586241003925GA0.5mm810123480395810123480678241004125GA0.5mm8101234803958101234819272410042241101825GA810123480319810123480593241004027GA8101234803268101234806092412026

What the firm is doing

On December 16, 2025, the firm began notifying customers via "URGENT: MEDICAL DEVICE RECALL" letters. Customers were instructed to discontinue use of affected product and to return product for Vortex Surgical to evaluate the seals; use UPS account 23623Y to ship unused products to Vortex Surgical Inc for replacement or refund at: Attn: Andrew Ritts Recall Tyvek Seal, Vortex Surgical Inc., 4 Research Park Dr., Suite 124, St. Charles, MO 63304; complete and return the Acknowledgement and Receipt Form via mail or email to: ARitts@VortexSurgical.com. Actions have been implemented to improve training of individuals associated with sealing and inspecting seals to prevent reoccurrence. The sealer associated with the issue is being updated to include a guard to prevent reoccurrence. If you have any questions, contact the Director of Regulatory Affairs at 635-778-4350 or email to: ARitts@VortexSurgical.com from 8am to 5pm.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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