Device recall

Z-2290-2014: PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve

FDA device recall · Class II · Pentax Medical Company

Key facts

Recall number (Z-number) Z-2290-2014
Recall event 68753
Product PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Product code KOG
Recalling firm Pentax Medical Company
Recall class Class II
Status Terminated
Termination date Aug 20, 2015
510(k) numbers K850020
FEI number 1000080301

At a glance

  • 1–9 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

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