Recall Z-1247-2026
Vortex Surgical Inc. · initiated December 16, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: 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…
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.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-1247-2026
- Initiated
- December 16, 2025
- Posted by FDA
- February 4, 2026
- Product code
- HNR – Forceps, Ophthalmic
- Quantity
- 14,789 (8651 US; 6138 OUS)
- Distribution
- 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.
- Recalling firm
- Vortex Surgical Inc., Saint Charles, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1244-2026 Class II | Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk…There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1245-2026 Class II | Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved…There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1246-2026 Class II | Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated…There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1248-2026 Class II | 25GA Subretinal Injection Cannula VS0220.25There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1249-2026 Class II | Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit -…There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1250-2026 Class II | Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1251-2026 Class II | Tecfen Retractable Membrane Polisher, QTPR1267-23There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1252-2026 Class II | Vortex Surgical I2 Injection Kit, VS0500There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1253-2026 Class II | Rumex Disposable Diamond Dusted ILM Elevator, 12-7523There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1254-2026 Class II | Vortex Surgical TID Pharos Illuminated Depressor, VS0801BXXX | 12/16/2025Open, Classified |
| Z-1255-2026 Class II | Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |
| Z-1256-2026 Class II | Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral MarkerThere may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots.… | 12/16/2025Open, Classified |