Device recall

Z-2479-2025: Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description…

FDA device recall · Class II · MEDLINE INDUSTRIES, LP - Northfield

Key facts

Recall number (Z-number) Z-2479-2025
Recall event 97388
Product Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR were distributed)
Product code FDE
Recalling firm MEDLINE INDUSTRIES, LP - Northfield
Recall class Class II
Status Open, Classified
FEI number 1417592

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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)