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U.S. Department of Health and Human Services

Class 2 Device Recall Tecfen

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 Class 2 Device Recall Tecfensee related information
Date Initiated by FirmDecember 16, 2025
Date PostedFebruary 04, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1251-2026
Recall Event ID 98255
Product Classification Hook, ophthalmic - Product Code HNQ
ProductTecfen Retractable Membrane Polisher, QTPR1267-23
Code Information Pouch UDI 817618024508 Box UDI 817618024508 Lot 2411013
Recalling Firm/
Manufacturer		 Vortex Surgical Inc.
4 Research Park Dr Ste 124
Saint Charles MO 63304-5639
For Additional Information ContactAndrew Ritts
1-636-7784350
Manufacturer 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 2		Employee error
ActionOn 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.
Quantity in Commerce14,789 (8651 US; 6138 OUS)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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