Recall Z-1250-2026
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 Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
Codes / lots: Pouch UDI 810123480456 Box UDI 810123480739 Lot 2410044
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-1250-2026
- Initiated
- December 16, 2025
- Posted by FDA
- February 4, 2026
- Product code
- MXY – Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
- 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-1247-2026 Class II | Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA…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-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 |