FDA Recall Open, Classified

Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23

Recall: Z-1218-2026 · Initiated December 5, 2025

Recall

Recall Number
Z-1218-2026
Event Number
98218
Firm
LimFlow, Inc.
FEI Number
3023527320
Product Code
MGZ
Status
Open, Classified
Root Cause
Process control
Initiated
December 5, 2025
Posted
January 29, 2026
Address
3031 Tisch Way, Ste 110, San Jose, CA, 95128-2541

Description

Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23

Reason

Incorrect expiration date

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.

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.

Quantity

33 units