Device recall

Z-2794-2026: Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain…

FDA device recall · Class II · Karl Storz Endoscopy

Key facts

Recall number (Z-number) Z-2794-2026
Recall event 99027
Product Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
Product code HIH
Recalling firm Karl Storz Endoscopy
Recall class Class II
Status Open, Classified
510(k) numbers K961605
FEI number 3007475226

At a glance

  • 1–9 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)