Brand Name: LimFlow Vector recallZ-1218-2026 · LimFlow, Inc. · initiated Dec 5, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from LimFlow, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect expiration date
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1218-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 5, 2025
- Posted by the FDA
- Jan 29, 2026
- Recalling firm
- LimFlow, Inc.
- Quantity
- 33 units
- Product code
- MGZ
- FDA submissions
- K221902
- 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.
Product description
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
Code information (models, lots, serial numbers)
Lot Code: Model: VT-US-23 Lot: 82321838 GTIN: 00850041730134 U.S. Product Code: MGZ
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LimFlow Vector VT-US-23Inari Medical, Inc. · Valvulotome1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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