Device recall

Z-2253-2023: Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion…

FDA device recall · Class II · Wilson-Cook Medical Inc.

Key facts

Recall number (Z-number) Z-2253-2023
Recall event 92648
Product Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.
Product code FFL
Recalling firm Wilson-Cook Medical Inc.
Recall class Class II
Status Open, Classified
FEI number 1037905

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)