Z-1218-2026Class II

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

Name: Z-1218-2026 Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
Creator: LimFlow, Inc.
Published: 2025-12-05
License: https://open.fda.gov/license/

LimFlow Inc. / initiated 2025-12-05 / Open, Classified / root cause: manufacturing process

FDA source

LimFlow, Inc. began a recall of Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23 on 2025-12-05. FDA classified it as Class II and gives the reason as "Incorrect expiration date". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1218-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-05
Posted: 2026-01-29
Recalling firm: LimFlow Inc.
Product: Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
Product code: MGZ Valvulotome
Reason for recall: Incorrect expiration date
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Lot Code: Model: VT-US-23 Lot: 82321838 GTIN: 00850041730134 U.S. Product Code: MGZ

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1218-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1218-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-29

Product code MGZ

K221902Class IILimFlow VectorLimFlow, Inc. / cleared 2022-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)