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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-1218-2026
Recalling firm
LimFlow, Inc.
Product
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
Status
Open, Classified
Initiated
2025-12-05
Posted
2026-01-29
Terminated
not on file
Reason
Incorrect expiration date
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
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.
Lot, serial or model codes
Lot Code: Model: VT-US-23 Lot: 82321838 GTIN: 00850041730134 U.S. Product Code: MGZ
510(k) numbers
["K221902"]
PMA numbers
not on file
Product code
MGZ
Firm FEI
3023527320
Firm city
San Jose
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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