Recall Z-1218-2026 ยท MGZ Valvulotome
LimFlow, Inc.
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
| Date | Jan 29, 2026 (initiated Dec 5, 2025) |
| Status | Open, Classified |
| 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 arran |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221902 | LimFlow Vector LimFlow, Inc., Dec 21, 2022 |