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U.S. Department of Health and Human Services

Class 2 Device Recall Vortex Surgical

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 Class 2 Device Recall Vortex Surgicalsee related information
Date Initiated by FirmNovember 19, 2025
Date PostedDecember 30, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1004-2026
Recall Event ID 98032
510(K)NumberK220263 
Product Classification Photocoagulator and accessories - Product Code HQB
ProductVortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Code Information UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040
FEI Number 3013002167
Recalling Firm/
Manufacturer		 Vortex Surgical Inc.
4 Research Park Dr Ste 124
Saint Charles MO 63304-5639
For Additional Information ContactAndrew Ritts
636-778-4350
Manufacturer Reason
for Recall		Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
FDA Determined
Cause 2		Component design/selection
ActionVortex Surgical Inc. issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/19/2025 via email. The notice explained the issue, risk to health, and requested the use of the product be discontinued. The firm requested the response to be emailed to: ARitts@VortexSurgical.com for replacement or refund. Customer Service will provide a return label for any unused products.
Quantity in Commerce221 units
DistributionUS and Japan
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.
510(K) Database510(K)s with Product Code = HQB
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