Device recall

Z-2401-2023: UroPass Ureteral Access Sheaths, 5 pieces/box

FDA device recall · Class II · Olympus Corporation of the Americas

Key facts

Recall number (Z-number) Z-2401-2023
Recall event 92495
Product UroPass Ureteral Access Sheaths, 5 pieces/box
Product code KNY
Recalling firm Olympus Corporation of the Americas
Recall class Class II
Status Open, Classified
510(k) numbers K051593
FEI number 2429304

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)