Class 2 Device Recall LimFlow Vector

• Date Initiated by Firm: December 05, 2025
• Date Posted: January 29, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1218-2026
• Recall Event ID: 98218
• 510(K)Number: K221902
• Product Classification: Valvulotome - Product Code MGZ
• Product: Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
• Code Information: Lot Code: Model: VT-US-23 Lot: 82321838 GTIN: 00850041730134 U.S. Product Code: MGZ
• FEI Number: 3023527320
• Recalling Firm/ Manufacturer: LimFlow, Inc.; 3031 Tisch Way Ste 110; San Jose CA 95128-2541
• Manufacturer Reason for Recall: Incorrect expiration date
• FDA Determined Cause: Process control
• Action: On December 11, 2025, Stryker ( LimFlow Inc.) issued a Urgent Medical Device Recall Notification letter. Stryker ask consignees to take the following actions: 1. Immediately check your internal inventory to locate the product(s) listed on the attached Business Reply Form, remove them from their point of use, and isolate/quarantine the unit(s) to prevent accidental use. 2. Sign and return the enclosed Business Reply Form by email to to confirm receipt of this notification/documenting product segregation. 3. Upon receipt of the completed Business Reply Form, Stryker will contact you to arrange for the return and replacement of your product(s). 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. If you have further distributed the affected product, please notify the applicable parties at once about this recall. You may copy and distribute this notification letter.
• Quantity in Commerce: 33 units
• Distribution: US Nationwide distribution in the states of AL, CT, District of Columbia, FL, KY, MA, MI, NE, NJ, NY, OH, PA, RI, TX, WY.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = MGZ